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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Therapy Arm | Experimental | Patients with EGFR-mutant advanced non-small cell lung cancer who achieve disease control after first-line osimertinib plus chemotherapy (FLAURA2 regimen) will receive local therapy (surgery or radiotherapy) to the primary tumor. The study will evaluate clinical outcomes including progression-free survival, overall survival, and treatment-related toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Therapy (Surgery or Radiotherapy) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 72 months (through June 30, 2031) |
| Local Control Rate |
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<Inclusion Criteria>
Participants must meet all of the following criteria to be eligible:
<Exclusion Criteria>
Participants will be excluded if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mi-Hyun Kim | Contact | 82-51-240-7845 | mihyunkim@pusan.ac.kr | |
| Soo Han Kim | Contact | 82-51-240-7845 | kshyjt1004@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mi-Hyun Kim | Pusan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Recruiting | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41234591 | Derived | Kim MH, Seong H, Kim SH, Eom JS. Local consolidative therapy for the primary tumor in EGFR-mutant advanced non-small cell lung cancer following osimertinib plus chemotherapy: a protocol for a single-arm, open-label, phase 2 trial. Transl Lung Cancer Res. 2025 Oct 31;14(10):4666-4674. doi: 10.21037/tlcr-2025-922. Epub 2025 Oct 29. |
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Single-arm study with local therapy after systemic treatment.
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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. |
| 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. | Up to 60 months (through June 30, 2030) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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