NCT06582771 A Study of Sotorasib in People With Non-Small Cell Lung Cancer
| NCT ID | NCT06582771 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Non Small Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2024-08-30 |
| Primary Completion | 2026-08 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 Criteria
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) * Alkaline phosphatase \< 2 x ULN (if liver or bone metastases are present,\< 3 xULN) * Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits * Serum creatinine \< 1.5 x ULN or if available, calculated or measured creatinine clearance \> 30 mL/min/1.73 m\^2 In addition, patients must: * Be willing to undergo pre-treatment and day 7-21 on-treatment tumor
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.