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RecruitingPhase 3

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)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares sotorasib plus two chemotherapy drugs with pembrolizumab plus two chemotherapy drugs as a first treatment. It is for people with advanced nonsquamous non-small cell lung cancer that has a KRAS G12C gene change and tests negative for PD-L1. The study looks at how long people live and how long they live without their cancer getting worse.

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have nonsquamous non-small cell lung cancer confirmed by a tissue or cell test. The cancer must be stage IV or advanced stage IIIB or IIIC.
  • The cancer must have a KRAS G12C gene change and test negative for PD-L1, a protein. A central lab must do or confirm the tests.
  • Have not received cancer drugs that work throughout the body for cancer that has spread or cannot be cured.
  • Be fully active or able to walk and do light work, even if heavy activity is limited.

Who can't join

  • Have lung cancer that includes small-cell cancer or large-cell neuroendocrine cancer, or is mostly squamous cell cancer.
  • Have a tumor with gene changes for which a targeted drug is locally approved as a first treatment.
  • Have cancer that has spread to the brain and causes symptoms, whether treated or not.
  • Have a digestive tract disease that prevents you from taking medicine by mouth.
  • Had a heart attack within 6 months before treatment group assignment, or have unstable heart rhythms or unstable chest pain from heart disease.
  • Have already received a drug that blocks KRAS G12C.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (30)

CA

DE

  • Medical Oncology Hematology Consultants Helen F Graham Cancer Center · Newark, DE 19713More trials in Newark

FL

IL

KY

MA

NC

NM

NY

OH

PA

SC

TN

TX

WA

WI