A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Recruiting now · Phase 3

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

In brief

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT06793215

Run by

Hoffmann-La Roche

People needed

600

Starts

2025-10-24

Expected to finish

2030-10-31

Last updated by the study team

2026-08-06

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
• Measurable disease, as defined by RECIST v1.1
• No prior systemic treatment for advanced or metastatic NSCLC
• Documentation of the presence of a KRAS G12C mutation
• Documentation of known PD-L1 expression status in tumor tissue
• Availability of a representative tumor specimen
• Adequate end-organ function
• Eligible to receive a platinum-based chemotherapy regimen
• Exclusion Criteria Related to NSCLC:
• Known concomitant second oncogenic driver with available targeted treatment
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization
• History of leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
• Exclusion Criteria Related to Current or Prior Treatments:
• Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study
• Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung >30Gy within 6 months prior to randomization
• Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
• Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors
• Current treatment with medications that are well known to prolong the QT interval
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization
• Prior allogeneic stem cell or solid organ transplantation
• Exclusion Criteria Related to General Health:

Where it is running

• City of Hope - Phoenix — Goodyear, Arizona, United States (enrolling)
• Community Cancer Institute (CCI) — Clovis, California, United States (enrolling)
• Marin Cancer Care Inc — Greenbrae, California, United States (enrolling)
• UCLA Oncology Center — Los Angeles, California, United States (enrolling)
• Hoag Memorial Hospital — Newport Beach, California, United States (enrolling)
• Palo Alto Medical Foundation Research Center — Palo Alto, California, United States (enrolling)
• Sutter Institute for Medical Research — Roseville, California, United States (enrolling)
• California Pacific Medical Center — San Francisco, California, United States (enrolling)
• UC Health Oncology Research — Colorado Springs, Colorado, United States (enrolling)
• Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System — Fort Collins, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Florida Cancer Specialists - SOUTH - SCRI - PPDS — Fort Myers, Florida, United States (enrolling)
• University of Florida Health at Shands — Gainesville, Florida, United States (enrolling)
• BioResearch Partner — Hialeah, Florida, United States (enrolling)
• Memorial Healthcare System - Memorial Regional Hospital — Hollywood, Florida, United States (enrolling)
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Ascension Sacred Heart — Pensacola, Florida, United States (enrolling)
• Florida Cancer Specialists - NORTH - SCRI - PPDS — St. Petersburg, Florida, United States (enrolling)
• Florida Cancer Specialists - EAST - SCRI - PPDS — West Palm Beach, Florida, United States (enrolling)
• Piedmont Cancer Institute, PC — Atlanta, Georgia, United States (enrolling)
• City of Hope® Atlanta — Newnan, Georgia, United States (enrolling)
• Summit Cancer Care PC — Savannah, Georgia, United States (enrolling)
• St. Luke's Cancer Institute — Boise, Idaho, United States (enrolling)
• Affiliated Oncologists, LLC — Chicago Ridge, Illinois, United States (enrolling)
• Alaska Oncology and Hematology — Anchorage, Alaska, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.