Efficacy of Non-Small Cell Lung Cancer Treatments
“A Study to Evaluate Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)”
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.
Drug - Alectinib
Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.
Drug - Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion Q21D.
Drug - Pemetrexed
Participants will receive pemetrexed 500 mg/m^2 IV infusion on Day 1 Q21D.
Drug - Cisplatin
Participants will receive cisplatin 75 mg/m^2 IV on Day 1 Q21D.
Drug - Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
Drug - Gemcitabine
Participants will receive gemcitabine 1000 or 1250 mg/m^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).
Drug - Entrectinib
Participants will receive entrectinib 600 mg orally QD.
A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)