Phase II Study of Iparomlimab and Tuvonralimab With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining anti-PD-1CTLA-4 antibodies with paclitaxel polymer micelles and platinum-based chemotherapy in patients with stage III unresectable non-small cell lung cancer. This Phase II clinical trial aims to observe how well this combination works and its safety profile in this specific group of lung cancer patients. The study is prospective, multicenter, open-label, and single-arm, focusing on patients meeting strict staging criteria according to the 8th edition of the AJCCUICC system. The treatment involves an induction therapy phase with Iparomlimab and Tuvonralimab combined with paclitaxel polymer micelles and platinum cisplatin or carboplatin, given via intravenous infusion in cycles every three weeks. This is followed by a local therapy phase where patients may undergo surgery or radiotherapy, based on a multidisciplinary team evaluation. After local therapy, patients receive consolidation therapy with apalotamab for up to one year, with additional chemotherapy at the physicians discretion. Participants will undergo screening within 21 days before starting treatment, followed by the treatment phases and a long-term follow-up period that includes safety monitoring and survival assessments. Researchers will measure outcomes such as objective response rate approximately four months after induction therapy, pathological remission rates, surgical success rates, and event-free survival up to 18 months and overall survival up to five years. Safety will be monitored from consent until 100 days after the last treatment dose, with additional biomarker and genetic analyses conducted within three years.

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