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Study of Divarasib and Pembrolizumab for KRAS G12C-Mutated Lung Cancer

This study is looking at two different treatment combinations for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change called KRAS G12C mutation. You might be eligible if your cancer has this mutation and hasn't been treated before. The study will compare a combination of Divarasib (an oral drug) and Pembrolizumab (given by IV) against Pembrolizumab combined with Pemetrexed and either Carboplatin or Cisplatin (all given by IV). Researchers want to see how well these treatments work to stop the cancer from growing and how they affect overall survival, as well as checking for side effects. The study plans to enroll about 600 participants, but its current status is unclear.

Study design
This study is an interventional study comparing two different drug combinations. It plans to enroll about 600 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 5 years to measure how long they live and how long their cancer is controlled.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06793215

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
PHASE3Ages 18+InterventionalTreatment
Hoffmann-La Roche
~600 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:DivarasibPembrolizumabPemetrexedCarboplatinCisplatin

At a glance

Recruiting sites
266 of 268 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Up to approximately 5 years
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer
KRAS G12C Lung Cancer

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Where it's being run

268 sites across 77 states
Germany23
Japan20
France14
Spain11
United Kingdom11
Poland10
China9
Florida8

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: CO45042 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)
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
History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \[OS\] rate \>90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
Significant cardiovascular disease within 3 months prior to screening

What this trial measures

  • Progression-Free Survival (PFS)Up to approximately 5 years

    PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)

  • Overall Survival (OS)Up to approximately 5 years

    OS is defined as the time from randomization to death from any cause