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NOT YET RECRUITING
NCT07822984
PHASE2

Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant NSCLC After First-Line Third-Generation EGFR-TKI Plus Chemotherapy

Sponsor: Fudan University

View on ClinicalTrials.gov

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

DRUG

Third-generation EGFR tyrosine kinase inhibitor

administered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol.

DRUG

Platinum plus pemetrexed chemotherapy

cisplatin or carboplatin plus pemetrexed for four 3-week cycles during induction.

DRUG

Pemetrexed maintenance therapy

administered with the third-generation EGFR-TKI until disease progression or unacceptable toxicity.

RADIATION

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.