Overview
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.
Description
This prospective, single-center, clinical trial aims to investigate the efficacy and safety of local therapy to the primary lung tumor in patients with EGFR mutation-positive advanced NSCLC who show a good response to first-line systemic therapy with osimertinib combined with platinum and pemetrexed (FLAURA2 regimen). Eligible patients who achieve complete response, partial response, or stable disease at the primary site after systemic therapy and meet predefined criteria will undergo surgery or radiotherapy to the primary lesion. The study will follow patients for progression-free survival, overall survival, and local control rate, as well as safety outcomes related to local therapy. No randomization or blinding is applied.
Eligibility
<Inclusion Criteria>
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.
<Exclusion Criteria>
Participants will be excluded if they meet any of the following criteria:
- 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.
- Active second malignancy requiring concurrent treatment.
- Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
- Pregnancy or breastfeeding at the time of enrollment.