A Single-arm Exploratory Study of Neoadjuvant Therapy

Summary

Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.

Timeline

Start

2022-08-01

Primary completion

2025-06-30

Completion

2025-12-30

Publications

• Background Chansky K, Detterbeck FC, Nicholson AG, Rusch VW, Vallieres E, Groome P, Kennedy C, Krasnik M, Peake M, Shemanski L, Bolejack V, Crowley JJ, Asamura H, Rami-Porta R; IASLC Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions. The IASLC Lung Cancer Staging Project: External Validation of the Revision of the TNM Stage Groupings in the Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2017 Jul;12(7):1109-1121. doi: 10.1016/j.jtho.2017.04.011. Epub 2017 Apr 28.
• Background Wozniak AJ, Gadgeel SM. Adjuvant therapy for resected non-small cell lung cancer. Ther Adv Med Oncol. 2009 Sep;1(2):109-18. doi: 10.1177/1758834009338634.
• Background Rosell R, Lopez-Cabrerizo MP, Astudillo J. Preoperative chemotherapy for stage IIIA non-small cell lung cancer. Curr Opin Oncol. 1997 Mar;9(2):149-55. doi: 10.1097/00001622-199703000-00008.
• Background Zhong WZ, Chen KN, Chen C, Gu CD, Wang J, Yang XN, Mao WM, Wang Q, Qiao GB, Cheng Y, Xu L, Wang CL, Chen MW, Kang X, Yan W, Yan HH, Liao RQ, Yang JJ, Zhang XC, Zhou Q, Wu YL. Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR-Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study. J Clin Oncol. 2019 Sep 1;37(25):2235-2245. doi: 10.1200/JCO.19.00075. Epub 2019 Jun 13.
• Background NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet. 2014 May 3;383(9928):1561-71. doi: 10.1016/S0140-6736(13)62159-5. Epub 2014 Feb 25.

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