Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ）

Phase 3 Recruiting 250 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 3, prospective, randomized, open-label, multi-center study that assesses the efficacy and safety of neoadjuvant therapy with different cycles of sintilimab combined with chemotherapy for Resectable Squamous Cell NSCLC. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

Timeline

Start: 2022-11-11
Primary completion: 2025-11-11
Completion: 2029-11-11

Publications

Zhang X, Shao M, Yao J, Zhao L, Li L, Chen M, Zhang Y, Liu H, Chen Z, Li B, Wu Z, Fan J, Qiu F. NeoSCORE II: three vs four cycles of neoadjuvant sintilimab + chemotherapy for squamous non-small-cell lung cancer. Future Oncol. 2024 Jan;20(3):121-129. doi: 10.2217/fon-2024-0026. Epub 2024 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Carboplatin	Small molecule	6 unknown	Intravenous
Subject	Paclitaxel	Small molecule	260 mg/m2	Intravenous
Subject	Sintilimab	Monoclonal antibody	200 mg	Intravenous

Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ）

Summary

Timeline

Publications

Drugs

Indications