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Active Not RecruitingPhase 3NCT06497556
Official study title

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

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDivarasib and Sotorasib

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?151 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Interventions being studied
Drug: Divarasib; Drug: Sotorasib; Drug: Adagrasib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Biomarkers
KRAS→
Treatment approach
Targeted therapy→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
  • Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Documentation of the presence of a KRAS G12C mutation
  • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of \>= 12 weeks
Reasons someone may not be able to joinExclusion criteria
  • Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
  • Malabsorption syndrome or other condition that would interfere with enteral absorption
  • Known concomitant second oncogenic driver
  • Mixed small-cell lung cancer or large cell neuroendocrine histology
  • Known and untreated, or active central nervous system (CNS) metastases
  • Leptomeningeal disease or carcinomatous meningitis
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
  • Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
  • Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
  • More than 30 Gy of radiotherapy to the lung within 6 months of randomization
  • Uncontrolled tumor-related pain
  • Unresolved toxicities from prior anticancer therapy
  • History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Banner Health MD Anderson AZGilbert, Arizona
  • Los Angeles Cancer NetworkLos Angeles, California
  • UCLA Hematology / Oncology ClinicLos Angeles, California
  • University of California, San FranciscoSan Francisco, California
  • Yale Cancer CenterNew Haven, Connecticut
  • University of MiamiMiami, Florida
  • Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)St. Petersburg, Florida
  • University of Chicago Medical CenterChicago, Illinois
  • New England Cancer SpecialistsWestbrook, Maine
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • University of MichiganAnn Arbor, Michigan
  • Cancer and Hematology Centers of Western MichiganGrand Rapids, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2026. Always confirm current availability with the study team.

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