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.
This prospective, single-arm, multicenter observational study is designed to estimate the median progression-free survival (PFS) in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who receive salvage local treatment after achieving disease control with first-line osimertinib plus chemotherapy. A total of 70 patients will be enrolled. The primary endpoint is median PFS, and the sample size was calculated to ensure that the 95% confidence interval around the estimated median has a width of no more than ±3 months, using Greenwood's approximation. Patients will be followed for a minimum of 24 months after the last enrollment, with an overall study duration of up to 72 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Patients 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.
Pusan National University Hospital
Busan, South Korea
RECRUITINGMedian 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.
Time frame: Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment)
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.
Time frame: Up to 72 months (through June 30, 2031)
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.
Time frame: Up to 60 months (through June 30, 2030)
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.
Time frame: Up to 60 months (through June 30, 2030)
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