Recruiting
Phase 2

Stereotactic Radiosurgery

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05419076

Conditions

Lung Cancer

Lung Cancer Metastatic

Brain Metastases

Brain Metastases, Adult

Small-cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiosurgery

Cerebrospinal fluid collection

Study Details

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.

Conditions

Lung Cancer

Lung Cancer Metastatic

Brain Metastases

Brain Metastases, Adult

Small-cell Lung Cancer

Study ID

NCT05419076

Start date

Jun 10, 2022

Status verified date

Jun, 2026

Completion date

Jun 10, 2027

Anticipated

Primary completion date

Jun 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

62 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with small cell lung cancer with brain metastases

Participants may be newly diagnosed small cell lung cancer with brain metastases at initial staging, or can alternatively be patients who develop brain metastases on therapy or during surveillance of systemic disease.

Interventions

Stereotactic Radiosurgery

All participants will undergo MSK standard SRS. A CT simulation will be performed per institutional standards, typically with contrast unless a contraindication exists. A contrast-enhanced MRI with 1mm slices will be fused to the CT simulation scan for the purposes of SRS planning. The SRS GTV will be considered the visible tumor on MRI and CT contrast enhanced studies. An expansion of 1-2mm will be used to create the PTV. Radiation dose may be between 16Gy and 30Gy in 1 to 5 fractions, per the discretion of the treating radiation oncologist. Participants with multiple lesions may receive different doses to each lesion per the discretion of the treating radiation oncologist. Concurrent treatment to other body sites is permitted.

Cerebrospinal fluid collection

All participants will undergo lumbar puncture for CSF collection at study enrollment.. Lumbar punctures will be performed by clinical staff in neurology or neuroradiology, per the discretion of the treating radiation oncologist, as dictated by scheduling limitations and expected clinical difficulty in obtaining a sample (e.g. requiring fluoroscopic guidance), with input from the PI, neurology, and/or neuroradiology as necessary. Participants will be encouraged to undergo repeat lumbar puncture for CSF collection at 3 months (+/- 4 weeks), and at the time of CNS disease progression, though these latter timepoints are not required. CSF cytology will be evaluated.

Primary outcome measure

  • Overall survival [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering at Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Luke Pike, MD

201-775-7604

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Luke Pike, MD

201-775-7604

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Luke Pike, MD

201-775-7604

Memorial Sloan Kettering Suffolk - Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Luke Pike, MD

201-775-7604

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Luke Pike, MD

201-775-7604

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Luke Pike, MD

201-775-7604

Memorial Sloan Kettering Nassau

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Luke Pike, MD

201-775-7604

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Stereotactic Radiosurgery
  • small cell lung cancer
  • small cell lung carcinoma
  • lung cancer
  • lung cancer metastatic
  • brain metastases
  • 22-133
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-10.