This is a single-arm, open-label, phase II study evaluating the clinical outcomes of local therapy (surgery or radiotherapy) to the primary tumor in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who have achieved disease control following first-line treatment with the FLAURA2 regimen (osimertinib plus platinum-based chemotherapy). The primary objective is to assess the median progression-free survival (PFS) after local therapy.
Age ≥ 20 years at the time of consent.
Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
Presence of activating EGFR mutation (exon 19 deletion or L858R).
Stage IV (metastatic) NSCLC at initial diagnosis.
Radiologic or clinical evidence of progressive disease during first-line osimertinib-chemotherapy.
Extensive, unresectable metastatic disease not amenable to local therapy.
Untreated or clinically unstable brain metastases.
Known contraindications to surgery or radiotherapy.
Single group
Local Therapy (Surgery or Radiotherapy)
Other interventionPatients will receive local therapy, either surgical resection or radiotherapy, to the primary lung tumor following disease control after first-line treatment with osimertinib plus platinum-based chemotherapy (FLAURA2 regimen). The specific modality (surgery or radiotherapy) will be determined based on tumor characteristics, patient condition, and multidisciplinary team assessment.
Median progression-free survival (PFS)
Time from the initiation of local therapy to the date of radiographic or clinical disease progression or death from any cause, whichever occurs first. Median PFS will be estimated using the Kaplan-Meier method.
Overall survival (OS)
Time from initiation of local therapy to death from any cause. OS will be estimated using the Kaplan-Meier method, and survival rates at predefined time points (e.g., 2-year OS) will also be reported.
Local Control Rate
Proportion of patients without local tumor progression at the treated site(s), assessed radiographically. Local control will be evaluated, including the 24-month local control rate.
Adverse events (AEs)
Incidence, type, and severity of treatment-related adverse events will be recorded. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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