drugset / Trial / NCT07124884
5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab
Phase 2
Not yet recruiting
300 enrolled
Federation Francophone de Cancerologie Digestive
Arbeitsgemeinschaft fur Internistische Onkologie · collabNorthwest Oncology Cooperative Group(GONO) · collabSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · collab
NaSingle-groupOpen-labelTreatment
Summary
5-fluorouracil (5-FU) is a standard of care in frail/elderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus Sotorasib are promising in advanced line in KRAS G12C mutated CRC. In this study, We assess the safety and efficacy of 5FU combination with Panitumumab and Sotorasib as first-line treatment in frail/elderly patients with unresectable KRAS G12C mutated CRC
Timeline
- Start
- 2025-08-31
- Primary completion
- 2030-06-30
- Completion
- 2030-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Sotorasib | Small molecule | 960 mg | Oral |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Levoleucovorin | Unknown | 200 mg/m2 | Intravenous |