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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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 (CodeBreaK 202)

Quick Facts

Study Start:2023-11-16
Study Completion:2031-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05920356

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * No history of systemic anticancer therapy in metastatic/non-curable settings
  3. * Eastern Cooperative Oncology Group (ECOG) ≤ 1
  1. * Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
  2. * Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
  3. * Symptomatic (treated or untreated) brain metastases
  4. * Gastrointestinal (GI) tract disease causing the inability to take oral medication
  5. * Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
  6. * Prior therapy with a KRAS G12C inhibitor

Contacts and Locations

Study Contact

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

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Sansum Clinic
Santa Barbara, California, 93105
United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
University of Illinois Chicago
Chicago, Illinois, 60612
United States
Illinois Cancer Specialists
Niles, Illinois, 60714
United States
Norton Cancer Institute - Brownsboro
Louisville, Kentucky, 40241
United States
Reliant Medical Group Inc
Worcester, Massachusetts, 01606
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke University
Durham, North Carolina, 27710
United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374
United States
Alliance Cancer Specialists - Media
Media, Pennsylvania, 19063
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, 37920
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
US Oncology Research Investigational Products Center
Irving, Texas, 75063
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-16
Study Completion Date2031-06-30

Study Record Updates

Study Start Date2023-11-16
Study Completion Date2031-06-30

Terms related to this study

Keywords Provided by Researchers

  • Oncology
  • Lung Cancer
  • PD-L1
  • KRAS p.G12C
  • Sotorasib
  • Pembrolizumab
  • Carboplatin
  • Pemetrexed
  • CodeBreaK 202
  • NSCLC
  • PD-L1 Negative
  • AMG 510
  • LUMAKRAS ®
  • LUMYKRAS ®

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer (NSCLC)