Iparomlimab and Tuvonralimab Plus Chemotherapy for Inducing Conversion to Resectability in Initially Unresectable Stage III NSCLC

Summary

This is a single-arm, multicenter Phase II clinical study designed to observe and evaluate the efficacy and safety of Iparomlimab and tuvonralimab plus chemotherapy in initially unresectable Stage III NSCLC. The study plans to enroll 69 Stage III NSCLC patients judged unresectable by a MDT team, with the R0 resection rate as the primary endpoint. After completing 2-4 cycles of conversion therapy, the MDT team reassesses resectability. Subjects deemed suitable for surgical resection undergo surgery within 6 weeks after the last dose of conversion therapy. Subjects deemed unsuitable for surgery receive radical chemoradiotherapy, starting within 6 weeks after the last conversion therapy dose. Subjects unsuitable for both surgery and chemoradiotherapy will have their subsequent treatment decided by the project team. Adjuvant therapy consists of Iparomlimab and tuvonralimab monotherapy (Q3W) for up to 16 cycles.

Timeline

Start

2025-10

Primary completion

2027-04

Completion

2029-06

Drugs

Indications