Stereotactic radiosurgery for lung cancer that has spread to the brain
A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)
This study is testing if a targeted radiation treatment can help people with small cell lung cancer that has spread to their brain feel better and improve their outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05419076 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of stereotactic radiosurgery (SRS) as a treatment for patients newly diagnosed with brain metastases from small cell lung cancer (SCLC). Participants will undergo SRS to target up to 10 brain metastases, with the aim of improving treatment outcomes. The study will include patients aged 18 and older who meet specific performance status criteria and have a confirmed diagnosis of SCLC. The research will assess the safety and efficacy of this intervention in managing brain metastases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histologic diagnosis of small cell lung cancer and up to 10 brain metastases.
Not a fit: Patients with leptomeningeal disease or those who have previously received brain-directed radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with brain metastases from small cell lung cancer.
How similar studies have performed: Other studies have shown promising results with stereotactic radiosurgery for brain metastases, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering at Basking Ridge — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Luke Pike, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Luke Pike, MD
- Email: PikeL@mskcc.org
- Phone: 201-775-7604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.