Status:
ACTIVE_NOT_RECRUITING
SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI
Lead Sponsor:
Fudan University
Conditions:
Brain Metastases
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with b...
Eligibility Criteria
Inclusion
- Pathologically confirmed non-small cell lung cancer;
- Clinical stage IV (AJCC, 8th edition, 2017);
- EGFR mutations: EGFR L858R, EGFR exon 19 deletion;
- Age ≥18 years;
- KPS score ≥70;
- Brain metastasis at the time of diagnosis;
- Complete baseline imaging assessment of metastatic lesions, including enhanced MRI for brain;
- Receiving first-line treatment with third-generation EGFR inhibitors;
- After 3-6 months of third-generation EGFR inhibitor treatment, imaging review indicates no progression of extracranial lesions, and brain lesions are evaluated by thin-layer (1mm layer) enhanced MRI, meeting the following criteria:
- No more than 10 remaining brain lesions;
- The maximum diameter of the remaining brain lesions does not exceed 3cm;
- At least one remaining brain lesion has a diameter greater than 5mm;
- After evaluation by the researcher, all remaining brain lesions are suitable for stereotactic radiotherapy.
- Patient informed consent.
Exclusion
- Poor compliance with the study protocol in the investigator's opinion;
- Patients withdrew their informed consent and requested to withdraw from the study;
- Patients were unable to receive regular doses of third-generation EGFR inhibitors due to other underlying conditions, viral side effects, economic factors, etc. (e.g., continuous discontinuation for more than 1 week, cumulative discontinuation for more than 2 weeks).
- Patients did not follow the protocol for follow-up visits as required by this study.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2028
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT06020066
Start Date
August 10 2023
End Date
August 10 2028
Last Update
September 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030