{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:27:54Z","timestamp":1792787274502,"version":"4.5.0"},"reference-count":20,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"unspecified","delay-in-days":21,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the Special Fund for Investigator-Initiated Trial (IIT) Projects of Zhejiang Cancer Hospital","award":["IIT2025ZB007"],"award-info":[{"award-number":["IIT2025ZB007"]}],"id":[{"id":"https:\/\/ror.org\/0144s0951","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,8,27]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Lung 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is a phase II, multicentre, single-arm, prospective clinical trial. The study includes patients with stage II\u2013IIIB 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\u2009mg\/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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ChiCTR2500104283<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-119512","type":"journal-article","created":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T18:35:46Z","timestamp":1790102146000},"page":"e119512","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Neoadjuvant QL1706 plus chemotherapy in patients with stage II\u2013IIIB squamous non-small cell lung cancer: study protocol for a prospective, single-arm, multicentre phase II trial"],"prefix":"10.1136","volume":"16","author":[{"given":"Ying","family":"Jin","sequence":"first","affiliation":[{"name":"Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, Zhejiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taobo","family":"Luo","sequence":"additional","affiliation":[{"name":"Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, Zhejiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0363-408X","authenticated-orcid":false,"given":"Jiadong","family":"Chu","sequence":"additional","affiliation":[{"name":"Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, Zhejiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Zeng","sequence":"additional","affiliation":[{"name":"Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, Zhejiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,9,22]]},"reference":[{"key":"2026092211353469000_16.9.e119512.1","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1016\/j.jtho.2017.11.111","article-title":"Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer","volume":"13","author":"Socinski","year":"2018","journal-title":"J Thorac Oncol"},{"key":"2026092211353469000_16.9.e119512.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2022.09.018"},{"key":"2026092211353469000_16.9.e119512.3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2202170"},{"key":"2026092211353469000_16.9.e119512.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2502931"},{"key":"2026092211353469000_16.9.e119512.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2302983"},{"key":"2026092211353469000_16.9.e119512.6","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)01756-2"},{"key":"2026092211353469000_16.9.e119512.7","unstructured":"National comprehensive cancer network . NCCN Guidelines Version 3.2026 Non-Small Cell Lung Cancer. Available: https:\/\/www.nccn.org"},{"key":"2026092211353469000_16.9.e119512.8","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1186\/s13045-023-01445-1","article-title":"First-in-human phase I\/Ib study of QL1706 (PSB205), a bifunctional PD1\/CTLA4 dual blocker, in patients with advanced solid tumours","volume":"16","author":"Zhao","year":"2023","journal-title":"J Hematol Oncol"},{"key":"2026092211353469000_16.9.e119512.9","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1038\/s41392-023-01731-x","article-title":"QL1706 (anti-PD-1 IgG4\/CTLA-4 antibody) plus chemotherapy with or without bevacizumab in advanced non-small cell lung cancer: a multi-cohort, phase II study","volume":"9","author":"Huang","year":"2024","journal-title":"Signal Transduct Target Ther"},{"key":"2026092211353469000_16.9.e119512.10","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1016\/S2213-2600(24)00269-8","article-title":"Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial","volume":"13","author":"Yue","year":"2025","journal-title":"Lancet Respir Med"},{"key":"2026092211353469000_16.9.e119512.11","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2304875"},{"key":"2026092211353469000_16.9.e119512.12","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2311926"},{"key":"2026092211353469000_16.9.e119512.13","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.24735"},{"key":"2026092211353469000_16.9.e119512.14","doi-asserted-by":"publisher","DOI":"10.1186\/s13046-019-1259-z"},{"key":"2026092211353469000_16.9.e119512.15","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-020-01224-2"},{"key":"2026092211353469000_16.9.e119512.16","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-022-02189-0"},{"key":"2026092211353469000_16.9.e119512.17","doi-asserted-by":"crossref","first-page":"1453","DOI":"10.1200\/JCO-24-02239","article-title":"Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer","volume":"43","author":"Awad","year":"2025","journal-title":"J Clin Oncol"},{"key":"2026092211353469000_16.9.e119512.18","doi-asserted-by":"crossref","first-page":"877","DOI":"10.1016\/S2213-2600(24)00185-1","article-title":"Comparison of platinum combination chemotherapy plus pembrolizumab versus platinum combination chemotherapy plus nivolumab-ipilimumab for treatment-naive advanced non-small-cell lung cancer in Japan (JCOG2007): an open-label, multicentre, randomised, phase 3 trial","volume":"12","author":"Shiraishi","year":"2024","journal-title":"Lancet Respir Med"},{"key":"2026092211353469000_16.9.e119512.19","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(20)30641-0"},{"key":"2026092211353469000_16.9.e119512.20","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.00975"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-119512","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T18:35:48Z","timestamp":1790102148000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-119512"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":20,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2026,9,22]]},"published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1136\/bmjopen-2026-119512"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-119512","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]}}}