Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer
a study on Lung Cancer Non-Small Cell Lung Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedestimated completion
Description
Summary
Phase 1b/Phase 2 open-label, multi-center, parallel group umbrella study. Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. The Phase1b part of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate the anti-tumor activity of the combination.
Official Title
A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants With Non-Small Cell Lung Cancer (NSCLC)
Keywords
Carcinoma, Non-Small-Cell Lung Non-Small-Cell Lung Carcinoma Sasanlimab Prefillled syringe Encorafenib Binimetinib Sub-Study A
Eligibility
You can join if…
Open to people ages 18 years and up
Umbrella Phase 1b & 2:
- Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC.
- At least one measurable lesion per RECIST v1.1 at Screening.
- ECOG Performance Status 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Adequate hepatic, renal, and bone marrow function.
Additional Inclusion Criteria for Sub-Study A Phase 1b &2:
-BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report.
Additional Inclusion Criteria for Sub-Study A Phase 1b only:
-Any line of therapy for locally advanced/metastatic NSCLC.
Additional Inclusion Criteria for Sub-Study A Phase 2 only:
-Previously untreated for locally advanced/metastatic NSCLC
You CAN'T join if...
Umbrella Phase 1b &2:
- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- Active, non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis.
- Active infection requiring systemic therapy.
- Clinically significant cardiovascular disease.
- Other malignancy within 2 years of first dose, with exceptions.
- Symptomatic brain metastasis, with exceptions.
Additional Exclusion Criteria for Sub-Study A Phase 1b &2:
- EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement.
- Prior treatment with any BRAF inhibitor or MEK inhibitor.
Additional Exclusion Criteria for Sub-Study A Phase 2 only:
-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
Locations
- UCSD Medical Center - Encinitas
accepting new patients
Encinitas California 92024 United States - UC San Diego Moores Cancer Center - Investigational Drug Services
accepting new patients
La Jolla California 92037-0845 United States - Sulpizio Cardiovascular Center at UC San Diego Health
accepting new patients
La Jolla California 92037 United States - UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
accepting new patients
La Jolla California 92037 United States - UCSD Perlman Medical Offices
accepting new patients
La Jolla California 92037 United States - UC San Diego Moores Cancer Center
accepting new patients
La Jolla California 92093 United States - UC San Diego Medical Center - Hillcrest
accepting new patients
San Diego California 92103 United States - UCSD Medical Center - Vista
accepting new patients
Vista California 92081 United States - Koman Family Outpatient Pavilion
accepting new patients
La Jolla California 92037 United States - California Cancer Associates for Research and Excellence, Inc (cCARE)
accepting new patients
Fresno California 93720 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Pfizer
- ID
- NCT04585815
- Phase
- Phase 1/2
- Study Type
- Interventional
- Last Updated