A Prospective Cohort Observational Study of Local Therapy for the Primary Tumor in EGFR-Mutant Advanced Non-Small Cell Lung Cancer Following Osimertinib Plus Chemotherapy (FLAURA2 Regimen)
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 1-year progression-free survival (PFS) after local therapy.
‣ Participants must meet all of the following criteria to be eligible:
• 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.
• Completion of four cycles of first-line osimertinib plus platinum-based chemotherapy (FLAURA2 regimen).
• Radiologic evidence of disease control (complete response, partial response, or stable disease) after systemic therapy.
• Residual primary lung tumor suitable for local therapy (surgery or radiotherapy), as determined by multidisciplinary evaluation.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function based on institutional laboratory criteria.
⁃ Ability to understand and willingness to provide written informed consent.