2024 World Conference on Lung Cancer (WCLC) - Posters-P3.08F.07 Efficacy and Safety of Envafolimab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB NSCLC

P3.08F.07 Efficacy and Safety of Envafolimab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB NSCLC

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This document outlines a clinical study aiming to investigate the efficacy and safety of Envafolimab combined with platinum-based chemotherapy as neoadjuvant therapy for patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC). Key eligibility criteria for patients include being 18 years old, having histologically confirmed NSCLC, being wild-type for EGFR and ALK, having an ECOG performance status of 0-1, and falling within stages IIA to IIIB (T3N2M0) of the disease.<br /><br />Envafolimab is a novel subcutaneous injection composed of a humanized camel-derived single-domain anti-PD-L1 antibody fused with a human IgG1 Fc fragment. This formulation is designed to be easy to administer, potentially enhancing patient compliance.<br /><br />This study is a prospective, open-label, single-arm trial enrolled at Zhongshan Hospital, Fudan University, Shanghai. During the treatment period, eligible patients will receive 300 mg of Envafolimab along with chemotherapy agents, including cisplatin or carboplatin with pemetrexed or docetaxel, administered in three 21-day cycles. Radical surgery is scheduled 4-6 weeks after completing the neoadjuvant therapy, with optional adjuvant therapy to follow. Study participants will be followed for up to three years unless they withdraw earlier.<br /><br />The primary endpoint of this study is the pathological complete response (pCR) rate, while secondary endpoints include event-free survival (EFS), major pathologic response (MPR) rate, R0 resection rate, safety, and quality of life. The findings from this study could contribute significantly to the existing knowledge on the use of PD-L1 antibodies as part of NSCLC treatment. The study is supported by the Beijing Bethune Charitable Foundation.

Asset Subtitle

Hongyu Zhang

Meta Tag

Speaker Hongyu Zhang

Topic Local-Regional NSCLC

Keywords

Envafolimab

platinum-based chemotherapy

neoadjuvant therapy

non-small cell lung cancer

NSCLC

PD-L1 antibody

pathological complete response

clinical study

Zhongshan Hospital

Beijing Bethune Charitable Foundation