NCT07082179 A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer
| NCT ID | NCT07082179 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangsu Cancer Institute & Hospital |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2027-12 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * 1\. Males or females aged 18 to 75 years. * 2\. Histologically or cytologically confirmed squamous or non-squamous (EGFR/ALK/ROS1 negative) non-small cell lung cancer. * 3\. No prior local treatment (surgery or radiotherapy) or any systemic anti-tumor treatment for the tumor, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, traditional Chinese medicine treatment, or any other investigational drug treatment. * 4\. Patients with unresectable stage III disease (according to the 8th edition AJCC TNM staging for non-small cell lung cancer, T1-2N2-3M0, T3N1-3M0, T4N0-3M0) after multidisciplinary team (MDT) assessment. * 5\. At least one measurable lesion according to RECIST v1.1 criteria, as shown by chest enhanced CT or PET/CT. * 6\. ECOG performance status: 0 or 1. * 7\. The patient is able to tolerate induction therapy and surgery. Radical surgical resection and systematic lymp