2024 World Conference on Lung Cancer (WCLC) - Posters-P1.09C.01 A Multicenter, Randomized, Phase II Trial of EGFR TKI with Primary Tumor Resection for EGFR-Mutant Metastatic NSCLC Patients

P1.09C.01 A Multicenter, Randomized, Phase II Trial of EGFR TKI with Primary Tumor Resection for EGFR-Mutant Metastatic NSCLC Patients

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The document outlines a multicenter, randomized Phase II trial (NCT05215548) investigating the efficacy of primary tumor resection combined with EGFR TKI (tyrosine kinase inhibitors) therapy in patients with EGFR-mutant metastatic non-small cell lung cancer (NSCLC). Conducted by Dobbie Pei-Hsing Chen at National Taiwan University Hospital, this study addresses the resistance encountered with current EGFR TKI treatments, which typically fail after one to two years due to intrinsic or acquired resistance.<br /><br />Several Phase II trials have explored local consolidation therapies in EGFR-mutant lung cancer to improve survival rates, yet there is no specific trial focusing on the efficacy of surgery on the thoracic tumor before disease progression. The rationale behind incorporating surgery lies in its potential to eliminate resistant tumor subclones and reduce tumor burden, thus minimizing the emergence of induced resistance. While not aiming to cure, this combined approach seeks enhanced control compared to standard EGFR TKI therapy alone.<br /><br />The trial protocol includes a thoracic surgery with the intent of achieving optimal locoregional disease control and a negative resection margin, with eligible patients continuing afatinib treatment post-surgery. Radiotherapy is optional for non-pulmonary lesions. The primary endpoint is the 2-year progression-free survival (PFS) rate, with secondary endpoints assessing overall survival, treatment-related adverse events, and pathology response rates.<br /><br />Recruitment, ongoing since January 2022, involves 100 patients from two hospitals in Taiwan, with 85 recruited and 66 randomized by August 2024. Completion is anticipated by December 2024. This trial is notable for examining thoracic surgery combined with EGFR TKI as a local treatment in stage IV non-oligometastatic NSCLC, providing new insights into treatment strategies. The study is partially funded by Boehringer Ingelheim, ensuring scientific integrity and independent editorial content.

Asset Subtitle

Pei-Hsing Chen

Meta Tag

Speaker Pei-Hsing Chen

Topic Metastatic NSCLC – Local Therapies

Keywords

multicenter trial

EGFR TKI therapy

non-small cell lung cancer

primary tumor resection

resistance mechanisms

thoracic surgery

progression-free survival

afatinib treatment

local consolidation therapy

Boehringer Ingelheim