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

NCT07550920 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-24

No results posted yet for this study

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).

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

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-10
Primary Completion
2027-03-30
Completion
2028-01-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07550920 on ClinicalTrials.gov