A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
Trial Status: active
The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).
Inclusion Criteria
- Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
- Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Documentation of the presence of a KRAS G12C mutation
- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of >= 12 weeks
Exclusion Criteria
- Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known concomitant second oncogenic driver
- Mixed small-cell lung cancer or large cell neuroendocrine histology
- Known and untreated, or active central nervous system (CNS) metastases
- Leptomeningeal disease or carcinomatous meningitis
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
- Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
- Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
- More than 30 Gy of radiotherapy to the lung within 6 months of randomization
- Uncontrolled tumor-related pain
- Unresolved toxicities from prior anticancer therapy
- History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Additional locations may be listed on ClinicalTrials.gov for NCT06497556.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Cindy Tong
Phone: 310-633-8400
Email: CMTong@mednet.ucla.edu
San Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not AvailableFairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not AvailableGreenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not AvailableGuilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not AvailableHartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: Active
Name Not AvailableNew Haven
Yale University
Status: Active
Name Not AvailableStamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not AvailableTorrington
Smilow Cancer Hospital-Torrington Care Center
Status: Active
Name Not AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableWaterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: Active
Name Not AvailableWaterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Name Not AvailableFlorida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not AvailableIllinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableBeth Israel Deaconess Medical Center
Status: Active
Name Not AvailableMichigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not AvailableNew York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not AvailableIcahn School of Medicine at Mount Sinai
Status: Active
Name Not AvailableNorth Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
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 AvailablePennsylvania
Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableVirginia
Richmond
VCU Massey Comprehensive Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationHoffmann-La Roche
- Primary IDBO45217
- Secondary IDsNCI-2024-06076, 2024-510908-37-00
- ClinicalTrials.gov IDNCT06497556