Efficacy and safety of envafolimab plus platinum-based chemotherapy as neoadjuvant therapy in resectable stage IIb-IIIb NSCLC: A single-arm, prospective, exploratory study.

• DOI: 10.1200/jco.2025.43.16_suppl.e20510
• Publication Date: 2025-05-28T17:43:48Z
• Authors: Tian Xia; Jianjun Wang; Zhikun Cao; Jiwei Li; Wenxue Wei; Wenping Zhang; Wenjian Yao; Mingliang Wang; Dong Yang; Chengzhi Ding; Zhijun Han; Shuai Hu; Zhaoyao Hou; Li Wei
• Keywords: Neoadjuvant Therapy

e20510 Background: Multiple clinical trials have reported the striking benefit for PD-1/PD-L1 monoclonal antibody combined with chemotherapy neoadjuvant therapy non-small cell lung cancer (NSCLC), while efficacy of subcutaneous injection anti-PD-L1 Envafolimab NSCLC patients has not been demonstrated yet. is a novel recombinant protein humanized camel-derived single-domain fused human IgG1 Fc fragment designed injection, making it easy to administer and improving patient compliance. This study aims investigate safety plus platinum-based as in resectable stage IIB-IIIB NSCLC. Methods: In this prospective, open-label, single-arm enroll histologically confirmed, potentially patients. Eligible will receive concurrent 300 mg (cisplatin 50~100mg/m 2 or carboplatin AUC = 4~6 pemetrexed 500mg/m docetaxel 60-75mg/m ) on day 1 three 21-day cycles. Radical surgery was scheduled within 4-6 weeks after last dose therapy, followed by optional adjuvant therapy. Follow up years unless subject withdraws. The primary endpoint major pathological response (MPR) rate. secondary endpoints included R0 resection rate, complete (pCR) safety. Results: Between May 2024 October 2025, 15 were enrolled, analysis. Neoadjuvant treatment started Surgery done 5 MPR achieved pCR No unacceptable toxicity treatment-related deaths occurred. Conclusions: As data reporting date, combination robust preliminary Therapy manageable profile. consist results from intravenous anti-PD-1 patients, envafolimab provided more convenient regimen population. Clinical trial information: 2400079595 .