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
Recruiting · NCT06793215 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 25 US states.
- Alaska Oncology and Hematology - Anchorage, Alaska, United States
- City of Hope - Phoenix - Goodyear, Arizona, United States
- Community Cancer Institute (CCI) - Clovis, California, United States
- Marin Cancer Care Inc - Greenbrae, California, United States
- UCLA Oncology Center - Los Angeles, California, United States
- Hoag Memorial Hospital - Newport Beach, California, United States
- Palo Alto Medical Foundation Research Center - Palo Alto, California, United States
- Sutter Institute for Medical Research - Roseville, California, United States
- California Pacific Medical Center - San Francisco, California, United States
- UC Health Oncology Research - Colorado Springs, Colorado, United States
- Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System - Fort Collins, Colorado, United States
- Hartford Hospital - Hartford, Connecticut, United States
- Florida Cancer Specialists - SOUTH - SCRI - PPDS - Fort Myers, Florida, United States
- University of Florida Health at Shands - Gainesville, Florida, United States
- BioResearch Partner - Hialeah, Florida, United States
- Memorial Healthcare System - Memorial Regional Hospital - Hollywood, Florida, United States
- Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- Ascension Sacred Heart - Pensacola, Florida, United States
- Florida Cancer Specialists - NORTH - SCRI - PPDS - St. Petersburg, Florida, United States
- Florida Cancer Specialists - EAST - SCRI - PPDS - West Palm Beach, Florida, United States
- Piedmont Cancer Institute, PC - Atlanta, Georgia, United States
- City of Hope® Atlanta - Newnan, Georgia, United States
- Summit Cancer Care PC - Savannah, Georgia, United States
- St. Luke's Cancer Institute - Boise, Idaho, United States
- Affiliated Oncologists, LLC - Chicago Ridge, Illinois, United States
- Hope and Healing Cancer Services - Hinsdale, Illinois, United States
- City of Hope® Cancer Center Chicago - Zion, Illinois, United States
- Mission Cancer + Blood - IMMC - Des Moines, Iowa, United States
- University of Iowa - Iowa City, Iowa, United States
- Saint Agnes Hospital - Baltimore - Hunt - PPDS - Baltimore, Maryland, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Profound Research, LLC - Farmington Hills, Michigan, United States
- Missouri Baptist Medical Center - St Louis, Missouri, United States
- NHO Revive Research Institute - Lincoln, Nebraska, United States
- Cancer Care Specialists - Reno, Nevada, United States
- San Juan Oncology Associates - Farmington, New Mexico, United States
- SUNY Upstate Medical University - Syracuse, New York, United States
- Montefiore Einstein Cancer Center - The Bronx, New York, United States
- Clinical Research Alliance - Westbury, New York, United States
- Firsthealth of The Carolinas - Pinehurst, North Carolina, United States
- Ohio State University - Columbus, Ohio, United States
- Oregon Health and Science University - Portland, Oregon, United States
- St. Luke's University Health Network - Bethlehem, Pennsylvania, United States
- Allegheny Cancer Center - Pittsburgh, Pennsylvania, United States
- Reading Hospital - McGlinn Cancer Institute - West Reading, Pennsylvania, United States
- Baptist Cancer Center - Memphis, Tennessee, United States
- The University of Texas Southwestern Medical Center at Dallas - Dallas, Texas, United States
- Renovatio Clinical - El Paso - El Paso, Texas, United States
- JPS Health Network - Fort Worth, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Community Clinical Trials - Kingwood, Texas, United States
- Texas Tech Health Science Center - Lubbock, Texas, United States
- Renovatio Clinical - The Woodlands, Texas, United States
- University of Texas Health Center at Tyler - Tyler, Texas, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- AZORG Campus Aalst-Moorselbaan - Aalst, Belgium
- Aarhus Universitetshospital - Aarhus N, Denmark
- Fujita Health University Hospital - Aichi, Japan
- NKI The Netherlands Cancer Institute - Amsterdam, Netherlands
- CHU Angers - Angers, France
Showing 60 of 268 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →