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Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant NSCLC After First-Line Third-Generation EGFR-TKI Plus Chemotherapy
Sponsor: Fudan University
Summary
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.
Official title: Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant Non-Small Cell Lung Cancer After First-Line Treatment With Third-Generation EGFR Tyrosine Kinase Inhibitor Plus Chemotherapy: A National Multicenter, Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
374
Start Date
2026-10
Completion Date
2030-09
Last Updated
2026-09-16
Healthy Volunteers
No
Interventions
Third-generation EGFR tyrosine kinase inhibitor
administered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol.
Platinum plus pemetrexed chemotherapy
cisplatin or carboplatin plus pemetrexed for four 3-week cycles during induction.
Pemetrexed maintenance therapy
administered with the third-generation EGFR-TKI until disease progression or unacceptable toxicity.
Consolidative stereotactic radiotherapy
SRS/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.