A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB VERSUS SOTORASIB OR ADAGRASIB IN PATIENTS WITH PREVIOUSLY TREATED KRAS G12C-POSITIVE ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
Contact:
NCT Number:
Protocol:
AAAV3951
Study Status:
Active/Enrolling
Population:
Adult
Phase:
III
The purpose of this study is to evaluate how well and how safely the experimental drug, divarasib, works compared to other approved drugs for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a mutation in the kirsten rat sarcoma virus (KRAS) G12C gene. This gene mutation drives cancer growth. The other approved treatments are sotorasib or adagrasib. The study drug, divarasib, is experimental, meaning it has not yet been approved by the U.S. Food and Drug Administration. While several drugs targeting this gene mutation have recently been developed, there is still a need for treatments that are more effective and have fewer side effects.
Are you Eligible? (Inclusion Criteria)
- 18 years of age or older at the time of signing Informed Consent Form 2. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception 3. 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 metastatic setting
Specialty Area(s)
Lung cancer, Immunotherapy
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032