A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
• Measurable disease, as defined by RECIST v1.1
• No prior systemic treatment for advanced or metastatic NSCLC
• Documentation of the presence of a KRAS G12C mutation
• Documentation of known PD-L1 expression status in tumor tissue
• Availability of a representative tumor specimen
• Adequate end-organ function
• Eligible to receive a platinum-based chemotherapy regimen
Locations
United States
Alaska
Alaska Oncology and Hematology
RECRUITING
Anchorage
Florida
BioResearch Partner
RECRUITING
Hialeah
Georgia
Summit Cancer Care PC
RECRUITING
Savannah
Illinois
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Michigan
Profound Research, LLC
RECRUITING
Farmington Hills
Texas
University of Texas Health Center at Tyler
RECRUITING
Tyler
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Chung Shan Medical University Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Reference Study ID Number: CO45042 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date:2025-12-01
Estimated Completion Date:2030-10-31
Participants
Target number of participants:600
Treatments
Experimental: Divarasib + Pembrolizumab
Participants will receive divarasib orally, once daily (QD) and pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W)
Active_comparator: Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin
Participants will receive pembrolizumab, pemetrexed and carboplatin or cisplatin via IV infusion Q3W