NCT06613633Completed
Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC
Pattern of Failure and Feasibility of Consolidative Stereotactic Radiotherapy in Third-generation EGFR-TKI-treated Metastatic EGFR-mutant Non-small Cell Lung Cancer: A Prospective, Observational Study
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The investigators plan to explore the time to achieve the best response after EGFR-TKI treatment, the characteristics of the distribution of lesions when the best response is achieved, the feasibility of SRT when the best response is achieved, and the phenotype of disease progression after EGFR-TKI resistance. In summary, this study will provide critical information for exploring the feasibility and optimal design of SRT as consolidation therapy for advanced NSCLC patients treated with third-generation EGFR-TKI, which will further promote the optimization of comprehensive treatment for EGFR-mutant advanced NSCLC.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 4000 (actual)
- First submitted
- 23 Sept 2024
- Start date
- 1 Sept 2018
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Fudan University
- Diseases
- Lung cancer
- NCT number
- NCT06613633
What you commit to
- Study type: Observational
- Participants enrolled: 4000
- From 1 Sept 2018 to the primary completion date, 1 Aug 2024
- 3 sites 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.
Other illness
- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
- Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
Lab values
- patients without EGFR sensitive mutations or with unknown EGFR mutation status.
- Withdrawal criteria
- Due to other underlying diseases, side effects, economic factors, and other reasons, patients did not receive regular doses of third-generation EGFR-TKI (continuous withdrawal time more than 1 week, cumulative withdrawal time more than 2 weeks, etc.).
Other
- Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
- The investigators considered that the patients had poor adherence to the study protocol.
- The patient withdrew informed consent and asked to withdraw.
- There was any safety reason (adverse event) considered by the investigator;
- The patient was not followed up according to the protocol.
- Other circumstances in which withdrawal from the study was deemed necessary by the investigator.
Who the study is looking for
- Pathologically confirmed non-small cell lung cancer;
- clinical stage IV (AJCC, 8th edition, 2017);
- EGFR sensitizing mutations (L858R or 19del);
- age≥18 years old;
- KPS score≥70;
- complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
- received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
- willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
- informed consent of the patient.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Wuhan Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.