A Phase 2 interventional study of Local Therapy (Surgery or Radiotherapy) in Non-Small Cell Lung Cancer and Epidermal Growth Factor Receptor, sponsored by Pusan National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Pusan National University Hospital · Phase 2, Interventional, and Treatment
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 70 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Pusan National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Participants must meet all of the following criteria to be eligible:
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Participants will be excluded if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Local Therapy (Surgery or Radiotherapy)
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.
This study also gives Osimertinib. No intervention listed here names it: that was found by reading the record.
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.
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)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Pusan National University Hospital