Phase II Study of Combined Neoadjuvant Chemotherapy, Chemoradiotherapy, and Dual Immune Checkpoint Blockade for Locally Advanced Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a treatment approach for patients with locally advanced non-small cell lung cancer NSCLC who have not had prior cancer treatments. The study focuses on combining neoadjuvant chemotherapy with dual immune checkpoint inhibitors targeting PD-1 and CTLA-4, along with bevacizumab and thymosin alpha 1, followed by chemoradiotherapy and a consolidation phase. The goal is to assess how effective and safe this combined treatment regimen is for this patient group. Participants first receive neoadjuvant chemotherapy including albumin-bound paclitaxel or pemetrexed, cisplatin, bevacizumab, iparomlimab, tuvonralimab, and thymosin alpha 1. Then they undergo concurrent chemoradiotherapy with hypofractionated radiotherapy, concurrent chemotherapy, and surufatinib. After that, patients receive consolidation therapy for one year consisting of iparomlimab, tuvonralimab, surufatinib, and thymosin alpha 1. This phased approach is designed to comprehensively treat the cancer with multiple therapies. Throughout the study, patients are monitored for progression-free survival over two years, response rates at two months after treatment, overall survival at two years, and treatment-related side effects for about 18 months. Assessments include clinical evaluations and safety monitoring during each phase of treatment and through follow-up. Participants may be involved for up to several years depending on their progression and response to therapy, with close observation to evaluate the treatment outcomes and safety.

A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer