Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSD
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to compare the efficacy of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Official Title

A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Details

The drug being tested in this study is called TAK-788. TAK-788 is being tested to evaluate the efficacy as a first line treatment compare with platinum-based chemotherapy in the participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 20 insertion mutations. The study will enroll approximately 318 patients. Participants will be randomly assigned to one of the two treatment groups- - TAK-788 group (Arm A) - Platinum-based chemotherapy group (Arm B) The participants will be administered with TAK-788 orally in arm A and Pemetrexed/Cisplatin or Pemetrexed/Carboplatin intravenously (IV) in arm B until the participants experience progressive disease (PD) as assessed by blinded independent review committee (IRC), intolerable toxicity or another discontinuation criteria. Participants in the chemotherapy group may cross over to treatment with TAK-788 after IRC-assessed PD is documented. Randomized treatment with TAK-788 or platinum-based chemotherapy may be continued after PD, at the discretion of the investigator and with the sponsor's approval, if there is still evidence of clinical benefit. This multi-center trial will be conducted in United States, Europe, and Asia. The overall time to participate in this study is until 3 years after the last participant is randomized. Participants will make multiple visits to the clinic and will be followed for survival, subsequent anticancer therapy, subsequent disease assessment outcome until disease progression on a subsequent anticancer therapy, and participant-reported health status (EQ-5D-5L) for 3 years after the last participant is randomized in the study and 30 days after the last dose of study drug for safety follow-up.

Keywords

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Drug Therapy Lung Neoplasms Carcinoma, Non-Small-Cell Lung Carboplatin Pemetrexed TAK-788 Cisplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
  • Documented epithelial growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (United States [US] sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations except EGFR mutations for which there are approved anti-EGFR TKIs (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid)
  • Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation
  • At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1
  • Life expectancy ≥3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

You CAN'T join if...

  • Received prior systemic treatment for locally advanced or metastatic disease
  • Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities
  • Received a moderate or strong cytochrome P-450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before randomization
  • Have been diagnosed with another primary malignancy other than NSCLC
  • Have current spinal cord compression or leptomeningeal disease
  • Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure
  • Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin

Locations

  • UC San Diego Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • University of California Irvine accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Millennium Pharmaceuticals, Inc.
ID
NCT04129502
Phase
Phase 3
Study Type
Interventional
Last Updated