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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
NSCLC
Interventions
DRUG

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

"Induction therapy regimen:Iparomlimab and Tuvonralimab 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, followed by cisplatin 70 mg/m² or carboplatin AUC 5 mg/mL/min. In cycle 2, if the patient's nadir neutrophil count is ≥1.0×10⁹/L and the nadir platelet count is ≥80×10⁹/L after cycle 1, and no grade II-IV non-hematologic toxicities have occurred, then paclitaxel polymer micelles 300 mg/m² will be administered via intravenous infusion over ≥3 hours, followed by cisplatin 70 mg/m² or carboplatin AUC 5 mg/mL/min.~The local treatment regimen is either surgery or standard radiotherapy. The consolidation therapy regimen consists of Iparomlimab and Tuvonralimab for 1 year , with the decision to combine with chemotherapy left to the discretion of the treating physician on an individual basis."

All Listed Sponsors
lead

Jiangsu Cancer Institute & Hospital

OTHER