NCT07082179

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes a screening period (the maximum time interval from screening to the start of treatment ≤21 days), a treatment period (including the induction therapy phase, local therapy phase \[surgery or radiotherapy\], and consolidation therapy phase), and a follow-up period (including safety follow-up and survival follow-up). The primary endpoint is the objective response rate after induction therapy. Secondary endpoints include the pathological complete response rate in operable patients, major pathological response rate, surgical conversion rate, R0 resection rate, and 18-month event-free survival rate, among others.

Conditions

• NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-04
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-07-24
• Last updated: 2026-02-11

Locations

1 site across 1 country: China