ArticleBMJ open2026
Neoadjuvant QL1706 plus chemotherapy in patients with stage II-IIIB squamous non-small cell lung cancer: study protocol for a prospective, single-arm, multicentre phase II trial.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionLung squamous cell carcinoma is a subtype of non-small cell lung cancer (NSCLC) and its biological characteristics or treatment responses might differ from non-squamous NSCLC. Although neoadjuvant immunotherapy combined with chemotherapy has become the guideline-recommended treatment for resectable NSCLC, clinical benefits remain suboptimal as a substantial proportion of patients fail to achieve pathological complete response (pCR). Hence, we conduct a clinical study on QL1706 combined with chemotherapy for the neoadjuvant treatment of squamous NSCLC.
methodsThis is a phase II, multicentre, single-arm, prospective clinical trial. The study includes patients with stage II-IIIB squamous NSCLC who are eligible or potentially eligible for surgical resection. Enrolled patients receive the neoadjuvant treatment regimen consisting of three cycles of QL1706 (5 mg/kg, d1, Q3W) combined with platinum-doublet chemotherapy. The primary endpoint is the pCR rate. The secondary endpoints are major pathological response, clinical response rate, R0 resection rate, event-free survival, overall survival, safety and tolerability, feasibility of surgery and incidence rate of complications during the perioperative period or within 90 days after the surgery. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of Zhejiang Cancer Hospital on 29 May 2025 (IRB-2025-667). The current study protocol version is V.5.0. Patient enrollment has been ongoing since October 2025. The results of this study will be presented to peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: ChiCTR2500104283.
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