Sotorasib vs Pembrolizumab for Non-Small Cell Lung Cancer

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 Phase 3 Interventional Study
Non-Small Cell Lung Cancer (NSCLC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
750 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for

This trial is looking for people with advanced non-small cell lung cancer who have a specific gene mutation. Participants will receive one of two treatment combinations and will be monitored for their cancer's progress.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have advanced stage IV or IIIB/C non-small cell lung cancer.
  • I have a KRAS G12C mutation.
  • I have not received any prior treatment for my cancer.
  • I have an ECOG score of 1 or lower.

You may not be able to join if

  • I have a different type of lung cancer, like small-cell or large-cell.
  • I have brain metastases that are causing symptoms.
  • I have gastrointestinal issues that prevent me from taking pills.
  • I had a heart attack in the last 6 months.
  • I have unstable heart conditions like arrhythmias or angina.
  • I have previously been treated with a KRAS G12C inhibitor.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

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.

Trial Locations
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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 system…
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