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

Running, not enrolling · Phase 3

Conditions studied: Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer

In brief

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).

Key facts

Study ID

NCT06497556

Run by

Hoffmann-La Roche

People needed

338

Starts

2024-09-23

Expected to finish

2029-11-30

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Angeles Cancer Network — Los Angeles, California, United States
• UCLA Hematology / Oncology Clinic — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg) — St. Petersburg, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• New England Cancer Specialists — Westbrook, Maine, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
• Minnesota Oncology Edina — Edina, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• Taylor Cancer Research Center — Maumee, Ohio, United States
• Oncology Associates of Oregon, P.C — Eugene, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Allegheny Cancer Center — Pittsburgh, Pennsylvania, United States
• Tennessee Oncology, PLLC - Chattanooga — Chattanooga, Tennessee, United States
• Baptist Clinical Research Institute — Memphis, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• JPS Health Network — Fort Worth, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Texas Oncology - Northeast Texas — Longview, Texas, United States
• Banner Health MD Anderson AZ — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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