A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Trial Status: active
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).
Inclusion Criteria
- Inclusion Criteria: - 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 Exclusion Criteria Related to NSCLC: - Known concomitant second oncogenic driver with available targeted treatment - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization - History of leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently) Exclusion Criteria Related to Current or Prior Treatments: - Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study - Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung >30Gy within 6 months prior to randomization - Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors - Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors - Current treatment with medications that are well known to prolong the QT interval - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization - Prior allogeneic stem cell or solid organ transplantation Exclusion Criteria Related to General Health: - History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival [OS] rate >90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer - Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan - Significant cardiovascular disease within 3 months prior to screening
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06793215.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Cheyone Evans
Phone: 213-247-4788
Email: CheyEvans@mednet.ucla.edu
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Contact: Stern Cancer Center
Phone: 877-827-8839
Email: ucstudy@hs.uci.edu
Florida
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: Active
Contact: Coral Olazagasti
Email: cxo379@miami.edu
Coral Springs
UM Sylvester Comprehensive Cancer Center at Coral Springs
Status: Active
Contact: Coral Olazagasti
Email: cxo379@miami.edu
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: Active
Contact: Coral Olazagasti
Email: cxo379@miami.edu
Doral
UM Sylvester Comprehensive Cancer Center at Doral
Status: Active
Contact: Coral Olazagasti
Email: cxo379@miami.edu
Gainesville
UF Health Cancer Institute - Gainesville
Status: Active
Name Not AvailableHollywood
UM Sylvester Comprehensive Cancer Center at Hollywood
Status: Active
Contact: Coral Olazagasti
Email: cxo379@miami.edu
Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Status: Active
Contact: Coral Olazagasti
Email: cxo379@miami.edu
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not AvailableNorth Miami
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
Status: Active
Contact: Coral Olazagasti
Email: cxo379@miami.edu
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: Active
Contact: Coral Olazagasti
Email: cxo379@miami.edu
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Approved
Name Not AvailableMassachusetts
Boston
Massachusetts General Hospital Cancer Center
Status: Active
Name Not AvailableDana-Farber Cancer Institute
Status: Active
Name Not AvailableNew York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not AvailableOhio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not AvailableOregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableHouston
UT MD Anderson Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationHoffmann-La Roche
- Primary IDCO45042
- Secondary IDsNCI-2025-08021
- ClinicalTrials.gov IDNCT06793215