NCT05789082

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Divarasib	Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle.
DRUG	Pembrolizumab	Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.
DRUG	Carboplatin	Participants will receive IV carboplatin Q3W for four 21-day cycles.
DRUG	Cisplatin	Participants will receive IV cisplatin Q3W for four 21-day cycles.
DRUG	Pemetrexed	Participants will receive IV pemetrexed Q3W.

Timeline

• Start date: 2023-06-20
• Primary completion: 2032-01-29
• Completion: 2032-01-29
• First posted: 2023-03-29
• Last updated: 2026-03-19

Locations

71 sites across 18 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study