NCT06497556

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).

Conditions

• Non-Small Cell Lung Cancer
• KRAS G12C Lung Cancer

Interventions

Type	Name	Description
DRUG	Divarasib	Divarasib will be administered orally QD
DRUG	Sotorasib	Sotorasib will be administered orally QD
DRUG	Adagrasib	Adagrasib will be administred orally BID

Timeline

• Start date: 2024-09-23
• Primary completion: 2027-09-30
• Completion: 2029-11-30
• First posted: 2024-07-11
• Last updated: 2026-01-20

Locations

151 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study