Actively Recruiting
Phase III Study Comparing Divarasib Plus Pembrolizumab to Pembrolizumab with Chemotherapy in Adults with Untreated KRAS G12C-Mutated Advanced Non-Squamous Non-Small Cell Lung Cancer
Led by Hoffmann-La Roche · Updated on 2026-08-06
600
Participants Needed
268
Research Sites
100 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
C
Chugai Pharmaceutical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC not eligible for curative surgery or definitive chemoradiotherapy
- Measurable disease as defined by RECIST v1.1
- No prior systemic treatment for advanced or metastatic NSCLC
- Presence of KRAS G12C mutation
- Known PD-L1 expression status in tumor tissue
- Availability of a representative tumor specimen
- Adequate end-organ function
- Eligible for platinum-based chemotherapy regimen
You will not qualify if you...
- Known second oncogenic driver with available targeted treatment
- Symptomatic, untreated, or actively progressing central nervous system metastases
- Untreated spinal cord compression or unstable disease after prior treatment
- History of leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Any anti-cancer systemic therapy within 21 days prior to randomization or expected during the study
- Radiation therapy within 2 weeks prior to randomization or lung radiation >30Gy within 6 months
- Prior treatment with KRAS G12C or pan-KRAS/RAS inhibitors
- Treatment with immunosuppressive or immunostimulatory medications
- Current use of medications known to prolong QT interval
- Recent therapeutic oral or IV antibiotics within 2 weeks
- Prior allogeneic stem cell or solid organ transplant
- History of other malignancies within 5 years except certain low-risk cancers
- Chronic diarrhea, short bowel syndrome, major gastrointestinal surgery, or active bowel inflammation
- History or evidence of pneumonitis or lung inflammation
- Significant cardiovascular disease within 3 months prior to screening
Research Team
R
Reference Study ID Number: CO45042 https://forpatients.roche.com/ No attachments to email below.
F
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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