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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: closed to accrual
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
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not Available
Fairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not Available
Greenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not Available
Guilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not Available
Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: Approved
Name Not Available
New Haven
Yale University
Status: Active
Name Not Available
Stamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not Available
Torrington
Smilow Cancer Hospital-Torrington Care Center
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Waterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: Active
Name Not Available
Waterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Approved
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center