NCT06020066Active, not recruitingPhase 2
SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI
Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Oligo-residual Intracranial Disease After First-line Third-generation EGFR Inhibitors: a Multicenter, Randomized Clinical Trial.
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
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 brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 202 (actual)
- First submitted
- 18 Aug 2023
- Start date
- 10 Aug 2023
- Primary completion date
- 10 Aug 2027
- Lead sponsor
- Fudan University
- Diseases
- Lung cancer
- NCT number
- NCT06020066
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 202
- From 10 Aug 2023 to the primary completion date, 10 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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).
Other
- Poor compliance with the study protocol in the investigator's opinion;
- Patients withdrew their informed consent and requested to withdraw from the study;
- Patients did not follow the protocol for follow-up visits as required by this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.