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RECRUITING
NCT07082179
PHASE2

A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer

Sponsor: Jiangsu Cancer Institute & Hospital

View on ClinicalTrials.gov

Summary

This study is a prospective, multicenter, open-label, single-arm Phase II clinical trial. The study recruits patients with stage III unresectable non-small cell lung cancer according to the 8th edition of the AJCC/UICC staging system. It aims to observe and evaluate the efficacy and safety of anti-PD-1/CTLA-4 antibody in combination with paclitaxel polymer micelles and platinum-based therapy for stage III unresectable non-small cell lung cancer.

Official title: The Efficacy and Safety of Iparomlimab and Tuvonralimab Combined With Paclitaxel Polymer Micelles and Platinum (Cisplatin/Carboplatin) in the Treatment of Stage III Unresectable Non-small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-09-04

Completion Date

2028-12

Last Updated

2026-02-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and Platinum (cisplatin/carboplatin)

The induction therapy regimen is as follows: Apalotamab: 5 mg/kg, every 3 weeks (q3w), administered via intravenous infusion. Paclitaxel polymer micelles in combination with platinum: In cycle 1, paclitaxel polymer micelles 230 mg/m² administered via intravenous infusion over ≥3 hours, with the option to escalate the dose in cycle 2 according to the instructions for use, followed by cisplatin 70 mg/m² or carboplatin AUC 5 mg/mL/min. The local treatment regimen involves re-evaluation by a multidisciplinary team (MDT), surgery, or radical radiotherapy or single fractionated segmental radiotherapy (two radiotherapy regimens for the investigator to choose from). The consolidation therapy regimen consists of apalotamab consolidation for 1 year or up to a maximum of 17 cycles, with the decision to combine with chemotherapy left to the discretion of the treating physician on an individual basis.

Locations (1)

Jiangsu Provincial Cancer Hospital

Nanjing, China