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Lung Cancer clinical trials at UC Cancer
101 research studies open to eligible people

  • A Dose Escalation and Cohort Expansion Study of CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-1 Antibody (Nivolumab) or in Combination With Nivolumab and Anti-CTLA4 Antibody (Ipilimumab) in Patients With Select Advanced or Metastatic Solid Tumors

    open to eligible people ages 18 years and up

    In this four part study, NKTR-214 will be administered in combination with nivolumab in Parts 1 & 2, and with nivolumab and ipilimumab in Parts 3 & 4. In Part 1, the safety, efficacy and recommended Phase 2 dose (RP2D) of NKTR-214 in combination with nivolumab will be determined. In Part 2, the clinical benefit, safety, and tolerability of combining NKTR-214 with nivolumab at the RP2D in select patients with Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma, or Triple Negative Breast Cancer. In Part 3, the safety, efficacy and RP2D of NKTR-214 in combination with nivolumab and ipilimumab will be determined. In Part 4, the clinical benefit, safety, and tolerability of the triplet combination will be evaluated in select patients with RCC or NSCLC. All three drugs target the immune system and may act synergistically to promote anti-cancer effects.

    at UCLA

  • A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549

    open to eligible people ages 18 years and up

    This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects with advanced solid tumors.

    at UCLA UCSD

  • A Phase 1b Dose Escalation/Expansion Study of Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies

    open to eligible people ages 18 years and up

    This phase I trial studies the best dose and side effects of abexinostat and how well it works with given together with pembrolizumab in treating participants with microsatellite instability (MSI) solid tumors that have spread to other places in the body. Abexinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving abexinostat and pembrolizumab may work better in treating participants with solid tumors.

    at UCSF

  • A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

    open to eligible people ages 18 years and up

    The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.

    at UCLA

  • A Study Evaluating MM-310 in Patients With Solid Tumors

    open to eligible people ages 18 years and up

    MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1 open-label study of MM-310 in patients with solid tumors. In the first part of the study, MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established. After an MTD of MM-310 as a monotherapy is established, an expansion cohort and MM-310 in combination with other therapies will be assessed.

    at UCSF

  • A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

    open to eligible people ages 18 years and up

    The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.

    at UCSF

  • A Study of an Experimental Combination of Injections and Radiation Therapy for Advanced Stage Solid Tumors

    “This study is being done to test a new therapy for advanced stage solid tumor cancers involving a combination of radiation and injections.”

    open to eligible people ages 18 years and up

    This is a phase I/II study that will evaluate the safety and toxicity of this combinatorial approach. Eligible patients >18 years of age with histologically proven metastatic NSCLC, melanoma, RCC, or HNSCC who have failed PD-1 / PD-L1 checkpoint blockade therapy will be enrolled. Patients must have a candidate treatment lesion (subcutaneous, nodal, or visceral) accessible and safe for radiotherapy and serial intralesional injections as specified by the protocol. They must also have at least one target lesion (distinct from treatment lesion and outside of treatment lesion radiation field) evaluable for response by RECIST. This study will consist of a phase I dose escalation using a standard 3+3 design to determine safety and MTD of intralesional IL-2 which will be dose escalated in conjunction with standard fixed doses of RT and Pembrolizumab. At the MTD there will be a phase II dose expansion which will incorporate a simon-two stage design to assess efficacy and safety. Patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy.

    at UC Davis

  • A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)

    open to eligible people ages 18 years and up

    This study is designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy will consist of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy will consist of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery will enter a surveillance period, which consists of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants will be monitored for disease recurrence and survival for up to 3 years after last dose of study drug.

    at UCLA

  • A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

    open to eligible people ages 18 years and up

    This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-1308, MK-4280, or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-1308, MK-4280, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

    at UCLA UCSF

  • A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

    open to eligible people ages 18 years and up

    The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.

    at UC Irvine

  • A Study of Experimental Combination Treatment With Osimertinib and Navitoclax For EGFR-Positive Non-small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when given together and to see how well they work in treating patients with previously treated epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has spread to other places in the body or has not responded to previous treatment with initial EGFR kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    at UC Davis

  • A Study of Experimental Medicine Atezolizumab for Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.

    at UC Davis

  • A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

    open to eligible people ages 18 years and up

    This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.

    at UCSF

  • A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in NSCLC Patients With EGFR Mutation Who Failed 1L or 2L EGFR TKI Therapy

    open to eligible people ages 18 years and up

    The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

    at UCLA

  • A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

    open to eligible people ages 18 years and up

    The purpose of this study is to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

    at UCLA

  • A Study of RO7198457 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors

    open to eligible people ages 18 years and up

    This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of RO7198457 as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody).

    at UCSF

  • A Study of the Safety and Effectiveness of the Experimental Medicine Tisotumab Vedotin for Solid Tumors

    open to eligible people ages 18 years and up

    This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. The treatment will be given to patients every three weeks.

    at UC Davis

  • A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

    at UCLA UCSD UCSF

  • A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

    open to eligible people ages 18 years and up

    This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

    at UC Davis UCSD

  • A Trial of TAK-788 (AP32788) in Non-small Cell Lung Cancer (NSCLC)

    open to eligible people ages 18 years and up

    The purpose of this phase 1/2 study is to evaluate the safety, recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics of oral TAK-788, anti-tumor activity of TAK-788 in participants with NSCLC with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2), and anti-tumor activity of TAK-788 in participants with solid tumors other than NSCLC with EGFR or HER2 mutations, and to explore relationship between tumor and/or plasma biomarkers, and TAK-788 efficacy, safety, and/or cytochrome P450 3A (CYP3A) induction. The study will also determine the efficacy of TAK-788 in participants with locally advanced metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations who have received at least 1 prior line of therapy for locally advanced or metastatic NSCLC.

    at UC Irvine UCLA UCSD

  • An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

    open to eligible people ages 18 years and up

    A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

    at UCLA

  • APL-101 Study for NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advance Solid Tumors

    open to eligible people ages 18 years and up

    The primary Phase 1 purpose of this study is to assess overall safety and tolerability and recommended Phase 2 dose (RP2D) of APL-101. The Phase 2 portion will assess efficacy of the dose determined in phase 1 in individuals with Non-Small Cell Lung Cancer with c-Met EXON 14 skip mutations and c-Met Dysregulation Advance Solid Tumors

    at UCSF

  • Astra Zeneca (Immuno Stereotactic Ablative Body Radiotherapy) ISABR Study: Randomized Phase I/II Study of Stereotactic Body Radiotherapy

    open to eligible people ages 18 years and up

    This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105 subjects into the study. After an initial safety sample of 15 individuals receiving durvalumab (MEDI 4736) and Stereotactic Ablative Body Radiotherapy (SABR), if it is shown to be safe to administer this combination of therapies, the next enrolled subjects will be randomized in a 1:1 fashion (each subject with a "50-50 chance" like the flip of a coin) to receive either SABR and durvalumab (MEDI 4736), or SABR alone. Once treatment is completed, all subjects will return to the University of California at Los Angeles (UCLA) for regular follow-up visits to check on their health and outcomes. At visits both prior to and after treatment special blood samples will be drawn to be studied by UCLA scientists to look into the basic science aspects of how durvalumab (MEDI 4736) and radiation work in the body. It is hoped that we will learn more about the basic safety and science of durvalumab (MEDI 4736) combined with Stereotactic Ablative Body Radiotherapy (SABR) vs. SABR alone, while extending the life and quality of life of these subjects.

    at UCLA

  • Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

    open to eligible people ages 18 years and up

    This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

    at UC Irvine UCSD UCSF

  • Biomarker/ALK Inhibitor Combinations in Treating Patients With Stage IV ALK Positive Non-squamous Non-small Cell Lung Cancer (The NCI-NRG ALK Protocol)

    open to eligible people ages 18 years and up

    This National Cancer Institute (NCI)-NRG ALK Protocol phase II trial studies how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV ALK positive non-squamous non-small cell lung cancer. Lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether a combination of biomarker/ALK inhibitors or chemotherapy may work better in treating patients with ALK positive non-squamous non-small cell lung cancer.

    at UCSD

  • Biomarkers for Risk Stratification in Lung Cancer

    open to eligible people ages 40 years and up

    This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, UCSF Medical Center, and the San Francisco General Hospital. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.

    at UCSF

  • Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

    open to eligible people ages 18 years and up

    The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

    at UC Irvine

  • Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

    open to eligible people ages 18 years and up

    The primary purpose of the study is to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

    at UCLA

  • Cancer Associated Thrombosis and Isoquercetin (CAT IQ)

    open to eligible people ages 18 years and up

    This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung cancer or colorectal cancer.

    at UC Davis

  • Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies

    open to eligible people ages 18 years and up

    RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

    PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.

    at UCLA UCSD

  • COM701 in Subjects With Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with a programmed cell death protein 1 (PD-1) inhibitor.

    at UCLA

  • Combination Immuno and Radiotherapy for Non Small Cell Lung Cancer

    “Cancer treatment combining immune system therapy and radiation therapy - for patients with Non Small Cell Lung Cancer.”

    open to eligible people ages 18 years and up

    This is a pilot, single center, open-label study to examine the ORR, safety, and toxicity of avelumab in combination with SAR in non-responding and progressing NSCLC patients previously treated with a PD-1 Inhibitor.

    at UC Davis

  • Combination of TATE and PD-1 Inhibitor in Liver Cancer

    open to eligible people ages 18-80

    This is a single center, open-label phase IIA study that investigates the preliminary efficacy of Trans-arterial Tirapazamine Embolization (TATE) treatment of liver cancer followed by a PD-1 checkpoint inhibitor (either nivolumab or pembrolizumab). Patients with four types of cancers will be enrolled, hepatocellular carcinoma (HCC), metastatic colorectal cancer (mCRC), metastatic gastric cancer and advanced non-small cell lung cancer. All enrolled patients need to have liver lesions.

    at UC Irvine

  • DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

    open to eligible people ages 45 years and up

    The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.

    at UCLA

  • DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer

    open to eligible people ages 50-79

    The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and non-invasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.

    at UCLA

  • DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-over-expressing and/or HER2-mutated advanced NSCLC subjects.

    at UCSD

  • Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer

    open to all eligible people

    This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

    at UC Davis UCSD

  • Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

    open to eligible people ages 18 years and up

    Sleep-disordered breathing at night is a common medical problem. It leads to daytime fatigue, impairment in concentration and daily activities, and a higher risk of cardiovascular disease and life-threatening events. A particularly common form is obstructive sleep apnea (OSA), and it is usually treatable with a high rate of patient satisfaction and improved quality of life using a continuous positive airway pressure (CPAP) device. Treatment of this condition improves nighttime low-oxygen levels by ensuring patency of the upper airways. Research shows that in cancer, sleep disordered breathing is frequent. Low oxygen levels overnight may cause tumors to grow: tumors deprived of oxygen grow more blood vessels to try to get more oxygen, and growing more blood vessels makes the tumor grow. This study aims to examine how treating sleep-disordered breathing may lessen blood-flow to lung tumors, and thus serve to ultimately block tumor growth. Participants of this study will undergo sleep study and receive CPAP therapy as a part of routine care.

    at UCSD

  • Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer

    open to eligible people ages 18 years and up

    This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.

    at UCSF

  • Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)

    open to eligible people ages 18 years and up

    The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

    at UCSF

  • EGFR Inhibitor AZD9291 (Osimertinib) and Monoclonal antibodies (Necitumumab) side effects and best dosing for Lung Cancer

    “This study looks at experimental immunotherapy combination: necitumumab and osimertinib in treating Stage IV or Recurrent lung cancer”

    open to eligible people ages 18 years and up

    This phase I trial studies the side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent) and who have progressed on a previous EGFR tyrosine kinase inhibitor. Immunotherapy with monoclonal antibodies, such as necitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may be a better treatment for EGFR-mutant non-small cell lung cancer.

    at UC Davis

  • Experimental Immunotherapy MPDL3280A (Atezolizumab) and Radiation to treat patients with lung cancer

    “Study of Experimental Immunotherapy (Atezolizumab) and high dose radiation (SAR) in Inoperable Stage 1 Non-Small Cell Lung Cancer”

    open to eligible people ages 18 years and up

    This phase I trial studies the side effects and best dose of atezolizumab that can be given together with stereotactic body radiation therapy (SBRT) in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Giving atezolizumab together with stereotactic body radiation therapy may kill more tumor cells and be a better treatment for non-small cell lung cancer that cannot be removed by surgery.

    at UC Davis

  • Experimental medicine and whole brain radiation therapy to treat patients with brain metastases from non-small cell lung cancer

    “Study looking at radiation therapy and experimental medicine, VX-970 for treatment of lung cancer with metastases to brain”

    open to eligible people ages 18 years and up

    This phase I trial studies the side effects and best dose of ATR kinase inhibitor M6620 (VX-970) when given together with whole brain radiation therapy in treating patients with non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors that have spread from the original (primary) tumor to the brain. ATR kinase inhibitor M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ATR kinase inhibitor M6620 together with radiation therapy may be a better treatment for non-small cell lung cancer, small cell lung cancer, or neuroendocrine tumors.

    at UC Davis

  • Experimental medicine in Treating Patients With HIV-Associated Hodgkin Lymphoma

    open to eligible people ages 18 years and up

    This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment, or solid tumors that have spread to other places in the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ipilimumab is an antibody that acts against a molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of your immune system by shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV associated classical Hodgkin lymphoma or solid tumors compared to ipilimumab with nivolumab alone.

    at UC Davis UCLA UCSD UCSF

  • Experimental Radiotracer Imaging Study for Cancer Patients

    open to eligible people ages 18 years and up

    This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.

    at UC Davis

  • Experimental treatment combination, immunotherapy, (pembrolizumab), and targeted chemotherapy, (trametinib) for lung cancer

    “Help us evaluate the effects of the combination of immunotherapy and targeted chemotherapy on non-small cell lung cancer”

    open to eligible people ages 18 years and up

    This phase Ib trial studies the side effects of pembrolizumab and trametinib in treating patients with non-small cell lung cancer and KRAS gene mutations that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and trametinib may work better in treating patients with non-small cell lung cancer.

    at UC Davis

  • Expressing Personalized Tumor Antigens Study

    open to eligible people ages 18 years and up

    This is a Phase 1, open-label, multicenter study of ADXS-NEO administered alone and in combination with pembrolizumab in subjects with select advanced or metastatic solid tumors. This study will be performed in 2 phases, a safety phase (Part A and Part B) and an efficacy phase (Part C).

    at UCLA

  • FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors

    open to eligible people ages 18-75

    This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: - Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. - Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors. - Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.

    at UCSD

  • First-in-human Study of DS-1062a for Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This study is one single group of participants with NSCLC who have not been cured by other treatments. It is the first time the drug has been used in humans, and will be in two parts. The primary purpose of the parts are: - Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a - Dose Expansion: To investigate the safety and tolerability of DS-1062a This study is expected to last approximately 2.5 years from the time the first subject is enrolled to the time the last subject is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects.

    at UCLA

  • Firstline Pembrolizumab Alone or in Combination With Pemetrexed and Carboplatin in Induction/Maintenance or Postprogression in Treating Patients With Stage IV Non-squamous Non-small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.

    at UC Davis

  • FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

    open to eligible people ages 18 years and up

    FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.

    at UCSD

  • G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer. The study is an open-label design, consists of 2 parts: safety, pharmacokinetic, and dose-finding portion (Part 1), and randomized portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients will be enrolled in the study.

    at UCLA

  • Genetic testing in screening patients with lung cancer that has been or will be removed by surgery.

    “Studying the genes in a patient's tumor cells may help determine the best treatment for patients that have certain genetic changes.”

    open to eligible people ages 18 years and up

    This phase III ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

    at UC Davis UCSD

  • Intratumoral Administration of CCL21-gene Modified Dendritic Cell With Intravenous Pembrolizumab for Advanced NSCLC

    open to eligible people ages 18 years and up

    This is a phase 1 trial of intratumoral administration of CCL21-gene modified dendritic cells combined with intravenous pembrolizumab for advanced non-small cell lung cancer. Up to 12 patients will participate in the dose escalation phase and during dose expansion, 12 patients will be evaluated. Before the first injection of dendritic cells, blood will be collected from the patient and leukapheresis will be performed. Dendritic cells obtained from this blood draw will be cultured and induced with Ad-CCL21 gene. Then, the patient's lung tumor will be injected with these modified dendritic cells. This injection will be followed by treatment with 200 mg intravenous pembrolizumab. Patients will receive an injection of Ad-CCL21 DC followed by treatment with pembrolizumab on Days 0, 21, and 42. After these three injections, patients will receive pembrolizumab 200 mg every three weeks for up to one year. From enrollment of the first patient to the last dose administered to the last subject, this study is anticipated to take approximately 5 years to complete.

    at UCLA

  • JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer

    open to eligible people ages 18-99

    To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC

    at UCSD

  • Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

    at UC Davis

  • Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

    open to eligible people ages 18 years and up

    This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

    at UC Davis UCSD

  • M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

    open to eligible people ages 18 years and up

    The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.

    at UC Irvine

  • Maintenance Chemotherapy with/without Stereotactic Body Radiation Therapy (SBRT) to treat Stage IV non-small cell lung cancer

    “Does SBRT and maintenance chemotherapy work better than maintenance chemotherapy alone?”

    open to eligible people ages 18 years and up

    This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

    at UC Davis UCSD

  • MPDL3280A and Stereotactic Ablative Radiotherapy in Patients With Non-small Cell Lung Cancer

    open to eligible people ages 19 years and up

    This pilot phase I trial compares administration schedules of anti-programmed cell death-1 ligand 1 (PD-L1) monoclonal antibody MPDL3280A and stereotactic ablative radiotherapy in treating patients with stage IV non-small cell lung cancer. Monoclonal antibodies, such as anti-PD-L1 monoclonal antibody MPDL3280A, may block tumor growth in different ways by targeting certain cells. Stereotactic ablative radiotherapy, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Giving anti-PD-L1 monoclonal antibody MPDL3280A with stereotactic ablative radiotherapy may be a better treatment for non-small cell lung cancer. However, it is not yet known what the best administration schedule is for these treatments.

    at UC Davis

  • Niraparib and Temozolomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy

    open to eligible people ages 18 years and up

    This phase Ib/II trial studies how well niraparib and temozolomide work in treating patients with extensive-stage small cell lung cancer with a complete or partial response to platinum-based first-line chemotherapy. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving niraparib and temozolomide may work better in treating patients with extensive-stage small cell lung cancer.

    at UCLA

  • Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

    open to eligible people ages 18 years and up

    This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018) 2. Epithelial tumors of major salivary glands (closed to accrual 03/20/2018) 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018) 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018) 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible 9. Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018) 10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018) 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018) 14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual 04/15/2019) 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual 04/15/2019) 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation (closed to accrual 3/15/2019) 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018) 21. Odontogenic malignant tumors 22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) 23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017) 24. Pheochromocytoma, malignant 25. Paraganglioma (closed to accrual 11/29/2018) 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018) 29. Malignant giant cell tumors 30. Chordoma (closed to accrual 11/29/2018) 31. Adrenal cortical tumors (closed to accrual 06/27/2018) 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017) 33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019) 34. Adenoid cystic carcinoma (closed to accrual 02/06/2018) 35. Vulvar cancer 36. MetaPLASTIC carcinoma (of the breast) 37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018) 38. Perivascular epithelioid cell tumor (PEComa) 39. Apocrine tumors/extramammary Paget's disease 40. Peritoneal mesothelioma 41. Basal cell carcinoma 42. Clear cell cervical cancer 43. Esthenioneuroblastoma 44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual) 45. Clear cell cervical endometrial cancer 46. Clear cell ovarian cancer 47. Gestational trophoblastic disease (GTD) 48. Gallbladder cancer 49. Small cell carcinoma of the ovary, hypercalcemic type 50. PD-L1 amplified tumors 51. Angiosarcoma 52. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 53). Small cell lung cancer is not eligible 53. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)

    at UC Davis UC Irvine UCSD

  • Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)

    open to eligible people ages 18 years and up

    The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an effect on cancer and body in combination with nivolumab, a standard treatment for metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that is not approved for use outside of research studies by regulatory agencies. Up to 38 patients will be enrolled.

    at UCSD

  • Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study

    open to eligible people ages 18-130

    The objective of this study is to investigate the safety, tolerability and antitumor activity of novel combination therapies administered in subjects with advanced EGFRm NSCLC

    at UCSF

  • Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery

    open to eligible people ages 18 years and up

    This phase II trial studies how well osimertinib works in treating participants with stage I-IIIA Epithelial Growth Factor Receptor (EGFR) -mutant non-small cell lung cancer before surgery. Osimertinib may stop the growth of tumor cells by blocking mutant EGFR signaling in cancer cells.

    at UCSF

  • Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases

    open to eligible people ages 18 years and up

    This phase II trial studies how well osimertinib with or without bevacizumab works in treating patients with EGFR positive non-small cell lung cancer that has spread to the brain. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving osimertinib with or without bevacizumab may work better in treating patients with non-small cell lung cancer.

    at UC Davis

  • Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This is a randomized single-institution, phase II, open-label clinical trial of neoadjuvant pembrolizumab with or without low-dose stereotactic radiation therapy (SRT) in stage I-IIIA non-small lung cancer (NSCLC) patients who are planned to undergo surgical resection of their lung cancer.

    at UCSF

  • PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

    open to eligible people ages 18 years and up

    The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive solid tumors. The study will expand to look at the selected dose in patients with breast cancer, gastric cancer and non-small cell lung cancer

    at UCLA

  • Phase 1 Study of the Highly-selective RET Inhibitor BLU-667 in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

    open to eligible people ages 18 years and up

    This is a Phase 1, open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of BLU-667 administered orally in patients with medullary thyroid cancer, RET-altered NSCLC and other RET-altered solid tumors.

    at UC Irvine

  • Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers

    open to eligible people ages 18 years and up

    This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

    at UCLA UCSF

  • Phase 1/2 Study of LOXO-292 in Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer

    open to eligible people ages 12 years and up

    This is a Phase 1/2, open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

    at UC Irvine UCLA UCSD UCSF

  • Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the efficacy of X-396.

    at UCSD

  • Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer

    open to eligible people ages 18-100

    The study will evaluate the clinical activity of nivolumab in combination with 3 separate investigational agents, glesatinib, sitravatinib, or mocetinostat.

    at UCLA UCSD UCSF

  • Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

    open to eligible people ages 18 years and up

    This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, UCC, (escalation phase), NSCLC and salivary gland cancer) not responding to standard therapy.

    at UCLA

  • Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy.

    open to eligible people ages 18 years and up

    This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.

    at UCLA

  • PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

    open to eligible people ages 18 years and up

    The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc

    at UCLA

  • PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL

    open to eligible people ages 18 years and up

    The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc

    at UCLA

  • Radiation Therapy Regimens in Treating Patients With certain Small Cell Lung Cancers Receiving chemotherapy

    open to eligible people ages 18 years and up

    Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

    at UC Davis

  • Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)

    open to eligible people ages 18 years and up

    This phase II Lung-MAP non-Match treatment trial studies how well ramucirumab and pembrolizumab work versus standard of care in treating patients with non-small cell lung cancer that is stage IV or has come back. Immunotherapy with monoclonal antibodies, such as ramucirumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in standard of care chemotherapy for non-small cell lung cancer, such as docetaxel, gemcitabine hydrochloride, and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ramucirumab and pembrolizumab together may work better in treating patients with non-small lung cancer compared to standard of care.

    at UC Davis UCSD

  • Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

    open to all eligible people

    This phase II Lung-MAP trial studies how well rucaparib works in treating patients with genomic loss of heterozygosity (LOH) high and/or deleterious BRCA1/2 mutation stage IV non-small cell lung cancer or that has come back. Rucaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    at UC Davis UCSD

  • Safety Study of MGD009 in B7-H3-expressing Tumors

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate the safety of MGD009 when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Assessments will be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity of MGD009.

    at UCLA UCSF

  • Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine

    open to eligible people ages 18 years and up

    In this study, Genocea is evaluating an investigational, personalized adjuvanted vaccine, GEN-009, that is being developed for the treatment of patients with solid tumors. A proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System) will be used to identify neoantigens in each patient's tumor that are recognized by their CD4 and/or CD8 T cells. ATLAS-identified neoantigens will then be incorporated into a patient's personalized vaccine in the form of synthetic long peptides (SLPs).

    at UCSD

  • Study CB-839 in Combination With Nivolumab in Patients With Melanoma, ccRCC and NSCLC

    open to eligible people ages 18 years and up

    This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.

    at UCLA

  • Study looking at immunotherapy treatment, after surgery and chemotherapy, to treat patients with lung cancer

    “Can immunotherapy help after surgery and chemotherapy to treat lung cancer?”

    open to eligible people ages 18 years and up

    This phase III ALCHEMIST trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

    at UC Davis UCSD

  • Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

    open to eligible people ages 18 years and up

    A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.

    at UCLA

  • Study of Experimental Medicine (Poziotinib) in Patients With Non Small Cell Lung Cancer

    “Experimental medicine poziotinib may "target" mutations and stop the growth of this type of cancer”

    open to eligible people ages 18 years and up

    This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in four patient cohorts for up to 174 previously treated NSCLC patients with any systemic therapy (Cohort 1: 87 patients with EGFR exon 20 insertion mutations, Cohort 2: 87 patients with HER2 exon 20 insertion mutations), up to 140 treatment-naive NSCLC patients (Cohort 3: 70 patients with EGFR exon 20 insertion mutations, Cohort 4: 70 patients with HER2 exon 20 insertion mutations). For Amendment 2, approximately 180 patients in Cohort 5 (60 patients per dose group), 30 patients in Cohort 6, and 30 patients in Cohort 7 are being added.

    at UCLA

  • Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    A Phase 1b/2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with Nivolumab in Patients with Advanced Solid Tumors Including Melanoma, Renal Cell Carcinoma (RCC), and Non-Small Cell Lung Cancer (NSCLC). The primary objective of this study is: -To evaluate the safety and tolerability of HBI-8000 when combined with a standard dose and regimen of nivolumab, to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) and to evaluate frequency and severity of toxicities of this combination treatment The secondary objectives of this study include: - To explore the efficacy of study treatment as measured by Objective Response Rate (ORR), Disease Control Rate (DCR), Clinical Benefit Rate (CBR), Duration of Response (DoR), Progression-Free Survival (PFS) in all subjects treated at RP2D - To obtain pharmacokinetics of twice weekly HBI-8000 when administered in combination with nivolumab administered once every two weeks (Phase 1b all sites; Phase 2 selected sites) - To characterize the effect of HBI-8000 on the electrocardiogram QT corrected (QTc) interval (Phase 1b only) Exploratory: -To investigate the kinetics and extent of histone acetylation in peripheral blood mononuclear cells (PBMC) at the RP2D of HBI-8000 (Phase 2 only) Dose Escalation (Phase 1b) will include up to 18 subjects, followed by Cohort Expansion (Phase 2) including up to 20 subjects per tumor indication at MTD and/or RP2D (including those treated in Phase 1b).

    at UCSD

  • Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.

    at UC Irvine

  • Study of safety and feasibility of personalized radiotherapy

    “Personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging to treat lung cancer”

    open to eligible people ages 18-80

    The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.

    at UC Davis

  • Studying Tumor Tissue Samples and Blood Samples to Learn More About DNA Changes in Patients With Lung Cancer

    “We hope to learn whether tumor genetics and tumor disappearance are related.”

    open to eligible people ages 18 years and up

    RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

    PURPOSE: This laboratory study is looking at tumor tissue samples and blood samples to learn more about DNA changes in patients with lung cancer.

    at UC Davis

  • Survival Prolongation by Rationale Innovative Genomics

    open to eligible people ages 18 years and up

    Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.

    at UCSD

  • T-Cell PET Imaging With [18F]F-AraG in Lung Cancer

    open to eligible people ages 18 years and up

    This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single [18F]F-AraG PET exam as part of this study. [18F]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of [18F]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.

    at UCSF

  • Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    This phase II trial studies how effective talazoparib and temozolomide are for treating participants with extensive-stage small cell lung cancer that has come back after an initial chemotherapy treatment. Talazoparib, a PARP inhibitor, may stop the growth of tumor cells by preventing them from repairing their DNA. Chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib and temozolomide may work better in treating participants with extensive-stage small cell lung cancer than either one alone.

    at UCLA

  • Targeted Chemotherapy, Crizotinib, or Placebo in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer after surgery

    “Can targeted chemotherapy, Crizotinib, stop the growth of tumor cells by blocking the a protein from working?”

    open to eligible people ages 18 years and up

    This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

    at UC Davis UCSD

  • Targeted chemotherapy (Ceritinib + Trametinib) in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

    “Can a combination chemotherapy therapy approach disrupt cancer cells growth and survival?”

    open to eligible people ages 18 years and up

    This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). The Phase I portion will investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK or ROS-1 rearranged NSCLC. The Phase II portion will investigate the clinical efficiency of the combination of ceritinib and trametinib in 3 single arm cohorts: ALKi (ALK inhibitor) naïve patients; post-crizotinib progressed disease (PD) patients; and PD second line ALK tyrosine kinase inhibitor (TKI) patients.

    at UC Davis UC Irvine UCLA UCSD UCSF

  • Targeted chemotherapy or placebo to treat patient with lung cancer that has been completely removed by surgery

    “Can targeted chemotherapy (Erlotinib) stop the growth of tumor cells by blocking some of the enzymes needed for cell growth?”

    open to eligible people ages 18 years and up

    This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    at UC Davis UCSD

  • Targeted therapy directed by genetic testing in treating patients with advanced solid tumors, lymphomas, or multiple myeloma

    “Will identifying genetic abnormalities in tumor cells help doctors plan better, more personalized treatment for cancer patients?”

    open to eligible people ages 18 years and up

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

    at UC Davis UC Irvine UCSD

  • Trametinib in Patients With Advanced Neurofibromatosis Type 1 (NF1)-Mutant Non-small Cell Lung Cancer

    open to eligible people ages 18 years and up

    Phase II trial to evaluate trametinib in patients with locally advanced non-squamous, non-small cell lung cancer (NSCLC) whose tumors harbor a non-synonymous NF-1 mutation, with progressive disease on at least one prior line of therapy.

    at UCSF

  • UCDCC#269: A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC.

    open to eligible people ages 18 years and up

    The advent of checkpoint blockade immunotherapy has revolutionized the management of metastatic non-small cell lung cancer (NSCLC). Despite the promising evidence for deep and durable responses with these agents the majority of patients fail to respond. The investigators hypothesize that a novel strategy combining radiotherapy and intralesional interleukin-2 (IL-2), a signaling molecule and member of the cytokine family involved in the activation of leukocytes and lymphocytes, may overcome resistance to checkpoint blockade therapy and offer significant clinical benefit to patients who fail to respond to checkpoint blockade alone. The investigators propose a microtrial testing the feasibility of a bold combinatorial immunotherapy strategy consisting of radiotherapy (RT), intralesional IL-2, and check-point blockade for metastatic non-small cell lung cancer patients who have progressed after checkpoint inhibition. IL-2 can upregulate PD-1 expression and activate T-cells.

    at UC Davis

  • VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in combination with a fixed dose of avelumab in patients with advanced non-small cell lung cancer. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) of VX15/2503 administered in combination with avelumab.

    at UCLA

  • Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Treating Patients With Limited Stage or Extensive Stage ...

    “Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking.”

    open to eligible people ages 18 years and up

    This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

    at UC Davis

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