Trial intelligence / Profile preview

Iparomlimab and Tuvonralimab plus Chemotherapy as Neoadjuvant Therapy for Resectable Stage III-N2b NSCLC

NCT07538193Phase 2

Key facts

Status: Not yet recruiting
Start: May 2026
Primary completion: May 2029
Countries: 1
Sponsor: Tangdu Hospital
Modality: Immune Checkpoint Inhibitors

Drugs: iparomlimabtuvonralimab
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label, single-arm trial of iparomlimab and tuvonralimab in non-small cell lung cancer (NSCLC), sponsored by Tangdu Hospital. Primary endpoint: Pathological Complete Response rate. Planned start May 2026; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Iparomlimab and Tuvonralimab plus Chemotherapy
Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous)

Who it enrols

Adult patients with completely resectable stage III-N2b NSCLC, ECOG PS 0-1, without EGFR or ALK mutations, and no prior anti-tumor therapy for the current lung cancer.

Endpoints

Primary

Pathological Complete Response rate9-15 weeks

Secondary

Major Pathological Response rate9-15 weeks
Objective Response Rate9-15 weeks
R0 Resection Rate9-15 weeks
Event-Free Survivalup to 2 years
Overall Survivalup to 2 years
Safety and Tolerabilityup to 90 days after last dose
Rate of Delayed or Cancelled Surgery6 weeks
Surgery Duration9-15 weeks

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