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NOT YET RECRUITING
NCT07550920
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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).

Official title: Efficacy and Safety of Rilapentib Alpha Combined With Monotherapy Chemotherapy for the Perioperative Treatment of Resectable Stage II-III Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC): A Single-Center Phase II Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-05-10

Completion Date

2028-01-30

Last Updated

2026-04-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Drug: Retlirafusp alfa

30mg/kg intravenously every 3 weeks (Q3W) for neoadjuvant and maintenance therapy

DRUG

Drug: Single-agent Chemotherapy

Nab-paclitaxel or pemetrexed (per histology), intravenously Q3W

OTHER

Procedure: Radical Surgery

Radical resection of lung cancer after neoadjuvant therapy