NCT05419076 A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain
| NCT ID | NCT05419076 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2022-06-10 |
| Primary Completion | 2027-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 62 participants in total. It began in 2022-06-10 with a primary completion date of 2027-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to see if stereotactic radiosurgery/SRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer/SCLC.
Eligibility Criteria
Inclusion Criteria: * Histologic diagnosis of small cell lung cancer * Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI * Age 18 and above * Performance status KPS 60-100/ECOG 0-2 * Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment * The patient or legally authorized representative is able to provide informed consent Exclusion Criteria: * Unable to undergo contrast-enhanced MRI brain * Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine * Pregnant or lactating women * Prior brain-directed radiotherapy * Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET/CT imaging, no more than 3 months before study enrollment
Contact & Investigator
Luke Pike, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05419076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05419076 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05419076 currently recruiting?
Yes, NCT05419076 is actively recruiting participants. Contact the research team at PikeL@mskcc.org for enrollment information.
Where is the NCT05419076 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT05419076 clinical trial?
NCT05419076 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Luke Pike, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 62 participants.
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