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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

NCT06497556 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DRUG

Divarasib

Divarasib will be administered orally QD

DRUG

Sotorasib

Sotorasib will be administered orally QD

DRUG

Adagrasib

Adagrasib will be administred orally BID

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2027-09-30
Completion
2029-11-30
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06497556 on ClinicalTrials.gov