Brain MetastasesPhase 2NCT06020066
SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI
A Phase 2 study testing EGFR-TK Inhibitor and Stereotactic radiotherapy in people with Brain Metastases and Non-small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial 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 brain metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases, Non-small Cell Lung Cancer
- What is being tested?
- EGFR-TK Inhibitor and Stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 10 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: 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.
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.
- Conditions
- Brain Metastases, Non-small Cell Lung Cancer
- Being tested
- EGFR-TK Inhibitor, Stereotactic radiotherapy
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR-TK InhibitorDrug
Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.
Stereotactic radiotherapyRadiation
Patients with oligo-residual intracranial disease after treatment with EGFR-TKI will be treated with SRS of all intracranial lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist.
| Study group | Role | What they receive |
|---|---|---|
| 3rd generation EGFR-TKI+SRS | Experimental | The experimental arm will undergo stereotactic radiotherapy targeting all residual lesions in the brain (completed in a single or multiple treatment courses within one month), while continuing EGFR-TKI therapy until disease progression or intolerable toxicity occurs. Receives: Drug: EGFR-TK Inhibitor; Radiation: Stereotactic radiotherapy |
| 3rd generation EGFR-TKI | Active comparator | The control group will receive 3rd generation EGFR-TKI until disease progression or intolerable toxicity occurs. Receives: Drug: EGFR-TK Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS was measured from the date of randomization to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death
Measured: Two years
Secondary outcomes (5)
Overall Survival
OS was defined as the time from the date of randomization until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
Measured: Three years
Intracranial progression-free survival
iPFS was defined as the time from the start of randomization to the occurrence of intracranial disease progression or death. If the subject first experiences extracranial disease progression (without concurrent intracranial disease progression), the date of first extracranial disease progression will be used as the cut-off date. For patients who have not progressed at the time of analysis, the date of their last contact will be used as the cut-off date.
Measured: Two years
Health-related quality of life per QLQ-C30
Health-related quality of life was evaluated using the QLQ-C30 questionnaires to assess health-related quality of life.
Measured: Two years
Health-related quality of life per QLQ-LC13
Health-related quality of life was evaluated using the QLQ-LC13 questionnaires to assess health-related quality of life.
Measured: Two years
Percentage of Participants With Adverse Events
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start10 Aug 2023
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
- Investigators
- Zhengfei Zhu, MD, Principal investigator, Fudan UniversityXuwei Cai, Principal investigator, Shanghai Chest HospitalQian Chu, Principal investigator, Tongji HospitalXiaorong Dong, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyLin Wu, Principal investigator, Hunan Cancer HospitalRongrong Zhou, Principal investigator, Xiangya Hospital of Central South UniversityGuang Han, Principal investigator, Hubei Cancer HospitalHui Zhu, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020066
- Sponsor's protocol ID
- 2306276-14
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06020066
- Acronym / sponsor ID
- 2306276-14
- Conditions
- Brain Metastases, Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3rd generation EGFR-TKI+SRS | Experimental | Drug: EGFR-TK Inhibitor, Radiation: Stereotactic radiotherapyThe experimental arm will undergo stereotactic radiotherapy targeting all residual lesions in the brain (completed in a single or multiple treatment courses within one month), while continuing EGFR-TKI therapy until disease progression or intolerable toxicity occurs. |
| 3rd generation EGFR-TKI | Active comparator | Drug: EGFR-TK InhibitorThe control group will receive 3rd generation EGFR-TKI until disease progression or intolerable toxicity occurs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR-TK InhibitorPatients will receive EGFR-TKI until confirmed progression or unacceptable toxicity. | Drug | 3rd generation EGFR-TKI, 3rd generation EGFR-TKI+SRS |
| Stereotactic radiotherapyPatients with oligo-residual intracranial disease after treatment with EGFR-TKI will be treated with SRS of all intracranial lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist. | Radiation | 3rd generation EGFR-TKI+SRS |
Primary outcome
Progression-free survival
Time frame: Two years
PFS was measured from the date of randomization to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death
5 secondary outcomes
Overall Survival
Time frame: Three years
Intracranial progression-free survival
Time frame: Two years
Health-related quality of life per QLQ-C30
Time frame: Two years
Health-related quality of life per QLQ-LC13
Time frame: Two years
Percentage of Participants With Adverse Events
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhengfei Zhu, MD principal investigator
Fudan University
Xuwei Cai principal investigator
Shanghai Chest Hospital
Qian Chu principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGFR-TK Inhibitor and Stereotactic radiotherapy in people with Brain Metastases and Non-small Cell Lung Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.