Comparing two treatments for advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sansum Clinic
  Santa Barbara, California, United States Recruiting
• Medical Oncology Hematology Consultants Helen F Graham Cancer Center
  Newark, Delaware, United States Recruiting
• Boca Raton Clinical Research Coral Springs
  Coral Springs, Florida, United States Recruiting
• Regis Clinical Research LLC
  Miami, Florida, United States Recruiting
• Florida Clinical Trials Group Tamarac
  Tamarac, Florida, United States Recruiting
• University of Illinois Chicago
  Chicago, Illinois, United States Recruiting

+368 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.