Divarasib for Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
This study is looking into a new treatment called divarasib for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change called a KRAS G12C mutation. You would be eligible if your cancer has this mutation. Researchers want to see how safe divarasib is, how your body handles it (pharmacokinetics), and how well it works. Divarasib might be given alone or with other anti-cancer drugs like pembrolizumab, carboplatin, cisplatin, or pemetrexed. The main goal is to track any side effects you might experience. The study aims to enroll about 320 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 320 participants.
- What's involved
- You would receive divarasib orally once daily for 21 days in each cycle. Other treatments like pembrolizumab, carboplatin, cisplatin, or pemetrexed would be given intravenously (IV) on specific schedules.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your adverse events (side effects) will be measured from the start of the study until 60 days after your last dose of treatment, or until you start another cancer therapy, for up to approximately 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05789082
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Recruiting
PHASE1Ages 18+InterventionalTreatmentHoffmann-La Roche
~320 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:DivarasibPembrolizumabCarboplatinCisplatinPemetrexed
At a glance
Recruiting sites
55 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Adverse Events (AEs)
Measured over Baseline until 60 days after the final dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 5 years)
Conditions
Where it's being run
71 sites across 29 statesCalifornia5
Japan5
South Korea5
Spain5
New York4
Belgium4
Taiwan4
Florida3
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Who to contact
Reference Study ID Number: BO44426 https://forpatients.roche.com/ No attachments to email below.
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Confirmation of Biomarker eligibility
Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
No prior systemic treatment for advanced unresectable or metastatic NSCLC
Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.
Exclusion
Known concomitant second oncogenic driver with available targeted treatment
Squamous cell histology NSCLC
Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)
Prior treatment with a KRAS G12C inhibitor
Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment
History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \>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
Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
Co-morbid condition that is an absolute contraindication to treatment with corticosteroids
Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation.
Participants with brain metastases for whom complete surgical resections is clinically appropriate
What this trial measures
- Percentage of Participants with Adverse Events (AEs)Baseline until 60 days after the final dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 5 years)