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RecruitingLast updated: 28 February 2024

Codebreak 202: This study is comparing the effectiveness of targeted therapy versus immunotherapy when given in addition to platinum chemotherapy in people with advanced non-small cell lung cancer who have not had prior treatment for their advanced diseaseA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms. 

In Arm 1 (Experimental), participants will receive targeted therapy (called sotorasib) in combination with platinum chemotherapy (carboplatin and pemetrexed). 

In Arm 2 (Active Comparator), participants will receive immunotherapy (called pembrolizumab) in combination with platinum chemotherapy (carboplatin and pemetrexed). 

Conditions

This trial is treating patients with non-squamous non-small cell lung cancer with KRAS p.G12c mutation and negative PD-L1 expression

Cancer

Lung Cancers Lung cancer

Age

People18 - 100

Phase

III

Trial Acronym

Codebreak 202

More information

Trial Identifiers

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Trial sponsor

Amgen

Scientific Title

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

Eligibility

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
  • 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

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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