NCT03178552

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

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)

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
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 (Cohorts C and F) or 1680 mg IV infusion Q4W starting on Day 29 (Cohort E).
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.
DRUG	Cobimetinib	Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.
DRUG	Vemurafenib	Participants will receive 960 mg PO BID on Days 1-21 of the initial run-in period, and 720 mg PO BID on Days 22-28 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period.
DRUG	Bevacizumab	Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.
DRUG	Divarasib	Participants will receive divarasib PO QD until disease progression or unacceptable toxicity.
DRUG	Docetaxel	Participants will receive IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity

Timeline

• Start date: 2017-09-22
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2017-06-07
• Last updated: 2026-03-09

Locations

164 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Israel, Italy, Japan, Mexico, New Zealand, Panama, Peru, Poland, Russia, Serbia, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study