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)

Purpose

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.

Condition

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sotorasib combined with carboplatin and pemetrexed 		Sotorasib administered in combination with carboplatin and pemetrexed.
  • Drug: Sotorasib
    Oral administration
    Other names:
    • AMG 510
    • LUMYKRAS ®
    • LUMAKRAS ®
Active Comparator
Pembrolizumab combined with carboplatin and pemetrexed 		Pembrolizumab administered in combination with carboplatin and pemetrexed.
  • Drug: Pembrolizumab
    Intravenous administration

Recruiting Locations

Sansum Clinic
Santa Barbara 5392952, California 5332921 93105

Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark 4143861, Delaware 4142224 19713

University of Illinois Chicago
Chicago 4887398, Illinois 4896861 60612

Illinois Cancer Specialists
Niles 4903730, Illinois 4896861 60714

Reliant Medical Group Inc
Worcester 4956184, Massachusetts 6254926 01606

University of New Mexico Cancer Center
Albuquerque 5454711, New Mexico 5481136 87131

Duke University
Durham 4464368, North Carolina 4482348 27710

FirstHealth Cancer Center
Pinehurst 4485272, North Carolina 4482348 28374

Alliance Cancer Specialists - Media
Media 4559575, Pennsylvania 6254927 19063

University of Tennessee Medical Center Knoxville
Knoxville 4634946, Tennessee 4662168 37920

Regional One Health
Memphis 4641239, Tennessee 4662168 38103

Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203

United States Oncology Regulatory Affairs Corporate Office
Nashville 4644585, Tennessee 4662168 37203

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

US Oncology Research Investigational Products Center
Irving 4700168, Texas 4736286 75063

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com