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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
374
administered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol.
cisplatin or carboplatin plus pemetrexed for four 3-week cycles during induction.
administered with the third-generation EGFR-TKI until disease progression or unacceptable toxicity.
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.
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.
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Intracranial Progression-Free Survival (iPFS)
Time frame: 4 years
Health-Related Quality of Life (HRQoL)
health-related quality of life assessed using the QLQ-C30 and QLQ-LC13 questionnaires
Time frame: 4 years
Incidence of Treatment-Related Toxicities
proportion of evaluable participants experiencing treatment-related toxicities, graded according to CTCAE version
Time frame: 4 years
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