NSCLC (Advanced Non-small Cell Lung Cancer)NCT07491211
Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and Brain Metastases From Non-small Cell Lung Cancer (NSCLC), run by Fudan University at 3 sites in China.
Trial summary
The goal of this retrospective real-world study is to evaluate the effectiveness and safety of first-line osimertinib combined with early intracranial stereotactic radiotherapy (SRT) in patients with EGFR-mutant non-small cell lung cancer (NSCLC) with symptomatic brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Osimertinib
- What is being tested?
- Osimertinib and intracranial stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 19 Jul 2019to 31 Mar 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include Stage IV EGFR-mutant NSCLC patients with symptomatic brain metastases who were initially treated with first-line Osimertinib and upfront intracranial SRT during the enrollment period meeting the inclusion and exclusion criteria. First-line therapy must be initated within 6 weeks after initial diagnosis of stage IV EGFRm NSCLC. The patients will be collected across multiple centers in China.
Who may be able to join
- Age ≥18 years, Male or female
- Pathologically confirmed Stage IV metastatic non-squamous non-small cell lung cancer (NSCLC) with documented positive EGFR sensitive mutation (EGFR 19del and L858R) and MRI confirmed brain metastases, diagnosed within 6 weeks prior to treatment initiation within baseline period
- Received first-line osimertinib monotherapy during observation period
- Upfront brain SRT during observation period
- Baseline ECOG scored 0-2
- Symptomatic brain metastases during baseline period*
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- Complete imaging evaluation of systemic lesions (including brain MRI) during baseline period and before osimertinib treatment
- At least 1 follow-up brain MRI during observation period
- Baseline BM: ≤10 Brain metastases, largest tumor <10 mL in volume and <3 cm in longest diameter; total cumulative volume ≤15 ml *Symptomatic brain metastases are defined as any neurological symptom in relation to the diagnosed BM, occurred within 30 days after brain metastases diagnosis.
Who cannot join
- Leptomeningeal metastases at stage IV NSCLC diagnosis
- Whole brain radiotherapy treated BM during observation period
- Patients received other systemic anti-tumor therapy in addition to osimertinib as 1L treatment during observation period
- Secondary or multiple primary tumors at stage IV NSCLC diagnosis
- Patients received any adjuvant targeted therapy after previous surgery
Trial locations and contacts
3 sites in 1 country.
China3 sites
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Shanghai Jiao Tong University Affiliated Chest Hospital
Shanghai
Wuhan Tongji Hospital
Wuhan, Hubei
About this study
Official title: Osimertinib With Intracranial Stereotactic Radiotherapy for Newly Diagnosed, Treatment Naive EGFR Mutation Non-Small Cell Lung Cancer With Symptomatic Brain Metastases: A Retrospective, Multicenter, Real-world Study
The goal of this retrospective real-world study is to evaluate the effectiveness and safety of first-line osimertinib combined with early intracranial stereotactic radiotherapy (SRT) in patients with EGFR-mutant non-small cell lung cancer (NSCLC) with symptomatic brain metastases. Eligible patients include adults with stage IV EGFR-mutant NSCLC who received first-line osimertinib monotherapy and early intracranial SRT. Data will be extracted from hospital medical records across multiple centers. The primary endpoint is real-world progression-free survival (rwPFS). Secondary endpoints include overall survival (OS), rwPFS2, time to next treatment or death (TTNT), and time to treatment discontinuation or death (TTD). Exploratory endpoints include CNS progression patterns, CNS progression-free survival (CNS PFS), CNS objective response rate (CNS ORR), and incidence of symptomatic CNS radiation necrosis.
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Osimertinib, Stereotactic Radiation
- Being tested
- Osimertinib, intracranial stereotactic radiotherapy
- Keywords
- NSCLC, brain metastases, Osimertinib, Stereotactic Radiation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Eligible patients received first-line osimertinib monotherapy for systemic treatment.
intracranial stereotactic radiotherapyRadiation
Early intracranial stereotactic radiotherapy (SRT) was administered for brain metastases before disease progression on first-line osimertinib. Treatment and follow-up data were collected retrospectively from hospital medical records.
| Study group | Role | What they receive |
|---|---|---|
| First-line osimertinib plus early intracranial SRT | Patients receiving first-line osimertinib combined with early intracranial stereotactic radiotherapy Receives: Drug: Osimertinib; Radiation: intracranial stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Progression-Free Survival (rwPFS)
The time from index date (i.e. first-line initiation) until documented disease progression or death, whichever occurs first. Any patient not known to have progressed or died at the time of analysis will have rwPFS censored at the date of last assessment showing no progression.
Measured: 5 years
Secondary outcomes (4)
Overall Survival (OS)
The time from index date until death due to any cause. Any patient not known to have died at the time of analysis will have OS censored at the date they were last known to be alive.
Measured: 5 years
rwPFS2
The time from index date to the earliest of the progression event (following the initial investigator-assessed progression) after first subsequent therapy, or death. Any patient not known to have progressed on first subsequent therapy or died at the time of analysis will have rwPFS2 censored at the date of last assessment showing no progression.
Measured: 5 years
TTNT (Time to Next Treatment or Death)
The time from index date to the start date of the first subsequent treatment or death, whichever occurs first. Any patient not known to have a subsequent treatment or died at the time of analysis will have TTNT cencored at the date of last follow-up without a record of new treatment.
Measured: 5 years
TTD (Time to Treatment Discontinuation or Death)
The time from first-line Osimertinib iniation to discontinuation due to any reason or death, whichever occurs first. Any patient not known to have discontinued first-line Osimertinib or died at the time of analysis will have TTD censored based on the last recorded date on which the patient was known to be on treatment..
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start19 Jul 2019
- Primary completion31 Mar 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491211
- Sponsor's protocol ID
- ESR-24-22678
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osimertinib With Intracranial Stereotactic Radiotherapy for Newly Diagnosed, Treatment Naive EGFR Mutation Non-Small Cell Lung Cancer With Symptomatic Brain Metastases: A Retrospective, Multicenter, Real-world Study
- ClinicalTrials.gov ID
- NCT07491211
- Acronym / sponsor ID
- ESR-24-22678
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Osimertinib, Stereotactic Radiation
- Keywords
- NSCLC, brain metastases, Osimertinib, Stereotactic Radiation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Mar 2026 (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.
The goal of this retrospective real-world study is to evaluate the effectiveness and safety of first-line osimertinib combined with early intracranial stereotactic radiotherapy (SRT) in patients with EGFR-mutant non-small cell lung cancer (NSCLC) with symptomatic brain metastases. Eligible patients include adults with stage IV EGFR-mutant NSCLC who received first-line osimertinib monotherapy and early intracranial SRT. Data will be extracted from hospital medical records across multiple centers. The primary endpoint is real-world progression-free survival (rwPFS). Secondary endpoints include overall survival (OS), rwPFS2, time to next treatment or death (TTNT), and time to treatment discontinuation or death (TTD). Exploratory endpoints include CNS progression patterns, CNS progression-free survival (CNS PFS), CNS objective response rate (CNS ORR), and incidence of symptomatic CNS radiation necrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-line osimertinib plus early intracranial SRT | – | Drug: Osimertinib, Radiation: intracranial stereotactic radiotherapyPatients receiving first-line osimertinib combined with early intracranial stereotactic radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include Stage IV EGFR-mutant NSCLC patients with symptomatic brain metastases who were initially treated with first-line Osimertinib and upfront intracranial SRT during the enrollment period meeting the inclusion and exclusion criteria. First-line therapy must be initated within 6 weeks after initial diagnosis of stage IV EGFRm NSCLC. The patients will be collected across multiple centers in China.
Key inclusion criteria (9 listed)
- Age ≥18 years, Male or female
- Pathologically confirmed Stage IV metastatic non-squamous non-small cell lung cancer (NSCLC) with documented positive EGFR sensitive mutation (EGFR 19del and L858R) and MRI confirmed brain metastases, diagnosed within 6 weeks prior to treatment initiation within baseline period
- Received first-line osimertinib monotherapy during observation period
- Upfront brain SRT during observation period
- Baseline ECOG scored 0-2
Key exclusion criteria (5 listed)
- Leptomeningeal metastases at stage IV NSCLC diagnosis
- Whole brain radiotherapy treated BM during observation period
- Patients received other systemic anti-tumor therapy in addition to osimertinib as 1L treatment during observation period
- Secondary or multiple primary tumors at stage IV NSCLC diagnosis
- Patients received any adjuvant targeted therapy after previous surgery
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 |
|---|---|---|
| OsimertinibEligible patients received first-line osimertinib monotherapy for systemic treatment. | Drug | First-line osimertinib plus early intracranial SRT |
| intracranial stereotactic radiotherapyEarly intracranial stereotactic radiotherapy (SRT) was administered for brain metastases before disease progression on first-line osimertinib. Treatment and follow-up data were collected retrospectively from hospital medical records. | Radiation | First-line osimertinib plus early intracranial SRT |
Primary outcome
Real-world Progression-Free Survival (rwPFS)
Time frame: 5 years
The time from index date (i.e. first-line initiation) until documented disease progression or death, whichever occurs first. Any patient not known to have progressed or died at the time of analysis will have rwPFS censored at the date of last assessment showing no progression.
4 secondary outcomes
Overall Survival (OS)
Time frame: 5 years
rwPFS2
Time frame: 5 years
TTNT (Time to Next Treatment or Death)
Time frame: 5 years
TTD (Time to Treatment Discontinuation or Death)
Time frame: 5 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 27 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and Brain Metastases From Non-small Cell Lung Cancer (NSCLC), run by Fudan University at 3 sites 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 9 inclusion and 5 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Real-world Progression-Free Survival (rwPFS) (time frame: 5 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 27 Mar 2026.