This national multicenter, randomized controlled clinical trial evaluates the safety and efficacy of consolidative stereotactic radiotherapy in patients with advanced EGFR-mutant non-small cell lung cancer who have oligo-residual disease after four cycles of first-line treatment with third-generation EGFR-TKI plus platinum-based pemetrexed chemotherapy. Eligible participants will be randomized 1:1 to continue third-generation EGFR-TKI plus pemetrexed maintenance therapy alone or to receive stereotactic radiotherapy to all oligo-residual lesions in addition to the same maintenance therapy. The primary endpoint is progression-free survival.
Histologically confirmed non-small cell lung cancer.
Clinical stage IV disease according to the AJCC 9th edition.
Sensitizing EGFR mutation: EGFR exon 19 deletion or EGFR L858R.
Age 18-75 years.
Double primary or multiple primary malignancies, except early skin cancer or cervical carcinoma in situ treated with curative intent and without recurrence or progression for at least five years.
Pregnancy or breastfeeding, or considered unsuitable by the investigator for PET/CT or brain MRI examination.
History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder that, in the investigator's judgment, may interfere with informed consent or participant compliance.
Residual lesions considered unsuitable for consolidative stereotactic radiotherapy after first-line third-generation EGFR-TKI plus chemotherapy.
Parallel
Third-generation EGFR tyrosine kinase inhibitor
Drugadministered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol.
Platinum plus pemetrexed chemotherapy
Drugcisplatin or carboplatin plus pemetrexed for four 3-week cycles during induction.
Pemetrexed maintenance therapy
Drugadministered with the third-generation EGFR-TKI until disease progression or unacceptable toxicity.
Consolidative stereotactic radiotherapy
RadiationSRS/SRT/SBRT delivered to all eligible intracranial and/or extracranial oligo-residual lesions, completed as a single course or in staged courses within one month.
Progression-Free Survival (PFS)
The time from randomization to disease progression or death of the patient. Patients who have not yet progressed at the time of analysis will be censored at the date of their last contact.
Overall Survival (OS)
Intracranial Progression-Free Survival (iPFS)
Health-Related Quality of Life (HRQoL)
health-related quality of life assessed using the QLQ-C30 and QLQ-LC13 questionnaires
Incidence of Treatment-Related Toxicities
proportion of evaluable participants experiencing treatment-related toxicities, graded according to CTCAE version
peripheral blood specimens
This study requires that peripheral blood specimens be collected as much as possible at the time points specified in the study, and that they be stored and processed in accordance with standard procedures, in order to explore the clinical value of liquid biopsy for oligo-residual disease prediction, early warning of drug resistance, and prognostic assessment.
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