RECRUITING

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)

Description

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC)
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Related Conditions:

Non-Small Cell Lung Cancer (NSCLC)

Study Overview

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Study Details

Study overview

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.

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)

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)

Condition
Non-Small Cell Lung Cancer (NSCLC)
Intervention / Treatment

-

Contacts and Locations

Santa Barbara

Sansum Clinic, Santa Barbara, California, United States, 93105

Newark

Medical Oncology Hematology Consultants Helen F Graham Cancer Center, Newark, Delaware, United States, 19713

Chicago

University of Illinois Chicago, Chicago, Illinois, United States, 60612

Niles

Illinois Cancer Specialists, Niles, Illinois, United States, 60714

Louisville

Norton Cancer Institute - Brownsboro, Louisville, Kentucky, United States, 40241

Worcester

Reliant Medical Group Inc, Worcester, Massachusetts, United States, 01606

Albuquerque

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States, 87131

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Durham

Duke University, Durham, North Carolina, United States, 27710

Pinehurst

FirstHealth Cancer Center, Pinehurst, North Carolina, United States, 28374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2031-06-30