(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.
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