A Phase 2 Study of First-line Sotorasib for Patients With Advanced KRAS G12C-mutant Non-small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center
Summary
The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a "first-line therapy" since their cancer became advanced.)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent * Biopsy-proven metastatic or recurrent non-small cell lung cancer * KRAS G12C mutation on prior tumor biopsy or cell-free DNA (cfDNA) testing * No prior therapy in the advanced setting * Measurable disease per RECIST 1.1 * Karnofsky performance status (KPS) ≥ 70% * Age ≥ 18 * Adequate organ function * Hemoglobin ≥ 9\^9 g/dL * Platelets ≥ 75 x 10\^9/L * Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L * AST \< 3 x ULN (if liver metastases are present, \< 5 x ULN) * ALT \< 3 x ULN (if liver metastases are present, \< 5 x ULN) * Alkali…
Interventions
- DrugSotorasib
Sotorasib 960 mg (8 pills) daily
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering WestchesterHarrison, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York