WCLC 2025 - Posters & ePosters-P3.18.20 PELAGOS: Integrating Surgery and Radiotherapy in EGFR-Mutant N3-Stage III NSCLC After Conversion Therapy

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This prospective, single-arm Phase II trial (ChiCTR2400093459) investigates a multimodal treatment strategy for treatment-naive patients with EGFR-mutant N3 stage III non-small cell lung cancer (NSCLC) in China, addressing a critical unmet need due to high locoregional recurrence rates in advanced N3 disease. The study enrolls 30 patients aged ≥18 years with ECOG performance status 0-1, confirmed EGFR mutations (exon 19 deletion or L858R), and measurable disease without critical structure invasion.<br /><br />The protocol begins with induction therapy combining almonertinib—a third-generation EGFR tyrosine kinase inhibitor—with platinum-based chemotherapy for three cycles. Following induction, a multidisciplinary team (MDT) assesses patients for local treatment eligibility. Those suitable undergo surgical resection of the primary tumor and ipsilateral hilar and mediastinal lymph nodes, followed by hypofractionated radiotherapy directed at N3 metastatic lymph nodes concurrent with almonertinib. Patients ineligible or unwilling to undergo surgery receive concurrent chemoradiotherapy instead. Maintenance therapy with almonertinib continues for up to three years or until progression or unacceptable toxicity.<br /><br />Primary outcome is the 2-year event-free survival rate; secondary endpoints include overall survival, surgical conversion rate, times to distant metastasis and local recurrence, adverse events, and patient-reported outcomes. Exploratory endpoints assess radiographic and pathological responses and surgical resection completeness.<br /><br />This integrated approach aims to leverage targeted systemic therapy, surgery, and radiotherapy to improve locoregional disease control and survival in a population with limited current options. Prior landmark trials (LAURA, ADAURA, POLESTAR) have demonstrated improved progression-free survival and reduced distant metastases with third-generation TKIs but locoregional relapse remains problematic. By combining induction almonertinib plus chemotherapy with local treatments and consolidated almonertinib, the study seeks to reduce recurrence risk and enhance long-term outcomes in aggressive N3-stage III EGFR-mutant NSCLC. Results will provide critical prospective evidence on the feasibility, safety, and efficacy of this multimodal strategy.

Asset Subtitle

Ailin Li

Meta Tag

Speaker Ailin Li

Topic Clinical Trials in Progress

Keywords

Phase II trial

EGFR-mutant NSCLC

N3 stage III lung cancer

almonertinib

platinum-based chemotherapy

surgical resection

hypofractionated radiotherapy

concurrent chemoradiotherapy

event-free survival

multimodal treatment strategy