drugset / Trial / NCT07550920

Relatrilfa-α Plus Single-Agent Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III NSCLC (Phase 2)

NCT07550920

Phase 2 Not yet recruiting 18 enrolled Tianjin Medical University Cancer Institute and Hospital
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

EvaluationDrugModalityDoseRoute
Subject Retlirafusp alfa Protein / enzyme biologic 30 mg/kg Intravenous
Background Paclitaxel Small molecule Intravenous
Background Pemetrexed Small molecule Intravenous