drugset / Trial / NCT07550920
Relatrilfa-α Plus Single-Agent Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III NSCLC (Phase 2)
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, single-arm, phase 2 trial evaluating the efficacy and safety of retlirafusp alfa combined with single-agent chemotherapy as neoadjuvant treatment for patients with resectable stage II-III EGFR/ALK wild-type non-small cell lung cancer (NSCLC).Eligible patients receive 4 cycles of neoadjuvant therapy, followed by curative surgery and 1-year maintenance therapy with retlirafusp alfa.Primary endpoints are pathological complete response (pCR) rate and safety. Secondary endpoints include major pathological response (MPR), event-free survival (EFS), and overall survival (OS).
Timeline
- Start
- 2026-05-10
- Primary completion
- 2027-03-30
- Completion
- 2028-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Retlirafusp alfa | Protein / enzyme biologic | 30 mg/kg | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |