(Barcelona, Spain September 9, 2025, 10:15 a.m. CEST / UTC +2) — A randomized Phase II trial from National Taiwan University Hospital reports early evidence that resecting the primary thoracic tumor following EGFR tyrosine kinase inhibitor (TKI) therapy may prolong disease control in patients with metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
The study was presented today at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer (WCLC).
The trial, which enrolled both oligometastatic and polymetastatic patients, is the first to assess surgical resection after targeted therapy in this setting. After 12 weeks of afatinib, patients were randomized to continue therapy or undergo primary tumor resection. The surgical arm also allowed for radiotherapy at the investigator’s discretion for non-pulmonary metastasis.
“Our study explores whether targeting residual disease through surgery can extend the benefits of EGFR TKI beyond standard monotherapy, the purpose of surgery is not curative, but rather to serve as part of a combination therapy to prolong the interval before drug resistance develops. said presenting author Dr. Pei-Hsing Chen of National Taiwan University Hospital. “The early results suggest this approach may improve progression-free survival while providing important tissue for molecular analysis.”
Dr. Chen and the research team enrolled 91 patients. After 12 weeks of afatinib, participants were randomized (1:1) to continue afatinib or undergo primary tumor resection with or without radiotherapy for distant. Surgery aimed for locoregional control and negative margins. The primary endpoint was two-year PFS; secondary endpoints included overall PFS and OS.
Dr. Chen singled out these key data points about the study:
- Hazard ratio for progression: 0.48 (95% CI: 0.25–0.93; P = 0.031).
- Major pathological response (MPR) observed in 29.4% (10/34); pCR in 5.9% (2/34). MPR has not yet correlated with improved survival.
- Exon 19 deletion subgroup showed higher MPR, but L858R subgroup had a lower HR for PFS.
- NGS of postoperative tissue (n=30): TP53 mutations in 36.6%, co-mutations in 50.0%.
- HRs for TP53 and co-mutations were 1.4 and 1.7, respectively (not statistically significant).
“Early PFS results are promising and the surgical approach provides access to postoperative pathological and molecular data, offering new insights for future subgroup selection,” Dr. Chen reported.
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.
About the WCLC:
The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc.iaslc.org/.