A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
NCT ID: NCT06741085
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
56 participants
INTERVENTIONAL
2024-12-13
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases
NCT03391362
Stereotactic Radiosurgery (SRS) for Spine Metastases
NCT00593320
Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer
NCT06686771
Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy
NCT05703269
Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma
NCT06014827
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
osimertinib and stereotactic radiosurgery (SRS)
osimertinib
oral EGFR-TKI
stereotactic radiosurgery (SRS)
0-20mm-18Gy x 1, 21Gy x 1 ,9Gy x 3
20mm or larger- 9Gy x 3, 6Gy x 5, 5Gy x 5
osimertinib alone (standard systemic therapy)
osimertinib
oral EGFR-TKI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
osimertinib
oral EGFR-TKI
stereotactic radiosurgery (SRS)
0-20mm-18Gy x 1, 21Gy x 1 ,9Gy x 3
20mm or larger- 9Gy x 3, 6Gy x 5, 5Gy x 5
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution
* At least one intact brain metastasis measuring ≥1 cm measurable by RANO-BM at baseline prior to TKI therapy initiation
* Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start)
\- Presence of detectable and non-progressing BM lesions on imaging consistent with viable residual disease
Exclusion Criteria
* Prior brain-directed radiotherapy
* Evidence of leptomeningeal disease on MRI total spine and/or lumbar puncture cytology. The latter are not mandated by protocol but are rather at the discretion of the treating medical team as clinically indicated.
* Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate intervention with SRS
* Active hematologic malignancy or a second solid tumor histology with known CNS tropism
* Patients who have undergone a therapeutic craniotomy for resection of one or more symptomatic brain metastasis are ineligible unless one or more additional intact BM remain unresected, and meets size criteria (e.g., a patient with removal of a 3cm symptomatic brain metastasis, but has an additional 1.25cm lesion remaining post-operatively, remains eligible for the study).
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
* Pregnant women or women who are breastfeeding or of childbearing potential. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 3 months after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)
* Progressive Disease (PD) with multiple lesions and/or other features that would warrant a change in systemic therapy, as determined by the primary treating provider
* Presence of BM not deemed safely treatable with SRS, as determined by a radiation oncologist
* Intracranial Complete Response (CR)
* More than 20 visible residual brain metastases at the time of enrollment (i.e. after initial treatment with TKI). However, no upper limit on the number of visible brain metastases is set at the time of initial diagnosis prior to treatment with TKI. For example, a patient who had 35 visible brain metastases at the time of diagnosis, but after three months of treatment with TKI had 10 visible brain metastases remaining will be eligible for enrollment and randomization
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luke Pike, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Helena Yu, MD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Rupesh Kotecha, MD
Role: primary
Luke Pike, MD
Role: primary
Luke Pike, MD
Role: primary
Luke Pike, MD
Role: primary
Luke Pike, MD
Role: primary
Luke Pike, MD
Role: primary
Luke Pike, MD
Role: primary
Luke Pike, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Memorial Sloan Kettering Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24-378
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.