Trial intelligence / Profile preview

Retlirafusp alfa + Chemotherapy in Stage II-III NSCLC

NCT07550920Phase 2

Key facts

Status
Not yet recruiting
Start
May 2026
Primary completion
Mar 2027
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Modality
Fc-Fusion Proteins
Conditions
non-small cell lung cancer (NSCLC)
01

Overview

Phase 2, open-label, single-arm trial of retlirafusp alfa in non-small cell lung cancer (NSCLC), sponsored by Tianjin Medical University Cancer Institute and Hospital. Primary endpoint: Pathological Complete Response Rate. Planned start May 2026; status: not yet recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Experimental: Retlirafusp alfa + Single-agent Chemotherapy

    Retlirafusp alfa + nab-paclitaxel or pemetrexed

03

Who it enrols

Treatment-naive patients aged 18-75 with resectable stage II-III NSCLC, ECOG 0-1. Adenocarcinoma must be EGFR/ALK wild-type. Adequate organ function required.

04

Endpoints

Primary

  • Pathological Complete Response Rate

Secondary

  • Major Pathological Response Rate

  • Event-Free Survival

  • Overall Survival

  • Pathological Response Rate

  • R0 resection rate

  • Changes in EORTC QLQ-C30 Scores

  • Recurrence-Free Survival

  • Number of positive lymph nodes

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