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Study Comparing Sotorasib and Pembrolizumab for Advanced Lung Cancer

This study is for people with advanced non-small cell lung cancer (NSCLC) that has a specific change in the KRAS gene (KRAS G12C mutation) and is negative for PD-L1. It compares two different treatment approaches: sotorasib given by mouth, combined with standard platinum doublet chemotherapy, versus pembrolizumab given intravenously (into a vein), also combined with platinum doublet chemotherapy. The main goals are to see if one treatment helps people live longer without their cancer growing (progression-free survival) and to see if one helps people live longer overall (overall survival). We expect to follow participants for about 2.5 years to measure these outcomes. The study plans to enroll 750 participants, but its current recruitment status is unclear.

Study design
This study plans to enroll 750 participants. It compares two different drug combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 2.5 years to measure progression-free survival and overall survival.

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

NCT05920356

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Amgen
~750 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:SotorasibPembrolizumab

At a glance

Recruiting sites
320 of 414 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS)
Measured over Approximately 2.5 years
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

414 sites across 138 states
France34
Turkey (Türkiye)22
Italy16
Greece13
Poland11
Hungary9
Romania8
South Korea8

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression-free Survival (PFS)Approximately 2.5 years

    PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).

  • Overall Survival (OS)Approximately 2.5 years

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