Third-generation EGFR tyrosine kinase inhibitor
Drugadministered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol.
NCT Number: NCT07822984
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 4 years
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
Time frame: 4 years
Time frame: 4 years
health-related quality of life assessed using the QLQ-C30 and QLQ-LC13 questionnaires
Time frame: 4 years
proportion of evaluable participants experiencing treatment-related toxicities, graded according to CTCAE version
Time frame: 4 years
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.
Fudan University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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