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Comparing two treatments for advanced lung cancer

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Phase 3 Interventional Amgen · NCT05920356

This study is testing whether a new drug called sotorasib with chemotherapy works better than pembrolizumab with chemotherapy for people with advanced lung cancer that has a specific KRAS mutation.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionspembrolizumab, chemotherapy
Locations380 sites (Santa Barbara, California and 379 other locations)
Trial IDNCT05920356 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of sotorasib combined with platinum doublet chemotherapy against pembrolizumab combined with platinum doublet chemotherapy in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) that has a specific KRAS mutation. The primary goal is to compare progression-free survival (PFS) between the two treatment groups. Participants must have a confirmed diagnosis of stage IV or advanced stage IIIB/C NSCLC and meet specific eligibility criteria regarding their cancer characteristics and prior treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals with stage IV or advanced stage IIIB/C nonsquamous NSCLC who have a KRAS p.G12C mutation and are negative for PD-L1 expression.

Not a fit: Patients with mixed histology NSCLC or those who have received prior treatment with a KRAS G12C inhibitor may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective front-line therapy option for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches targeting KRAS mutations in lung cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
* No history of systemic anticancer therapy in metastatic/non-curable settings
* Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria:

* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
* Symptomatic (treated or untreated) brain metastases
* Gastrointestinal (GI) tract disease causing the inability to take oral medication
* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
* Prior therapy with a KRAS G12C inhibitor

Where this trial is running

Santa Barbara, California and 379 other locations

+330 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerOncologyLung CancerPD-L1KRAS p.G12CSotorasibPembrolizumabCarboplatin
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.