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drugset / Trial / NCT03178552

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

NCT03178552 ↗

Phase 2/3 Active not recruiting 1000 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-09-22
Primary completion
2026-10-31
Completion
2026-10-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1680 mg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Carboplatin Small molecule 6 unknown Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Divarasib Small molecule — Oral
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Entrectinib Small molecule 600 mg Oral
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1250 mg/m2 Intravenous
Subject Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods. Unknown 60 mg Oral
Subject 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. Unknown 600 mg Oral
Subject 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. Unknown 750 mg Oral
Subject 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. Unknown 900 mg Oral
Subject 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. Unknown 1200 mg Oral
Subject 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. Unknown 720 mg Oral
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

non-small cell lung carcinoma