A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain

Phase 2

Recruiting

• Conditions: Brain Metastases; Lung Cancer Metastatic; Lung Cancer; Small Cell Lung Carcinoma; Brain Metastases, Adult; Small-cell Lung Cancer
• Interventions: Radiation: Stereotactic Radiosurgery; Procedure: Cerebrospinal fluid collection

• Registration Number: NCT05419076
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-10
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Histologic diagnosis of small cell lung cancer
• Radiographic diagnosis of up to 10 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 or spine
• 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with small cell lung cancer with brain metastases	Stereotactic Radiosurgery	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.
Participants with small cell lung cancer with brain metastases	Cerebrospinal fluid collection	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	6 months	The primary endpoint of this study is the rate of overall survival at 6 months, with time measured from the start of SRS treatment. Participants will be censored at the date of last follow up or the last date the participant was known to be alive.

Trial Locations

Locations (8)

Memorial Sloan Kettering Nassau; 🇺🇸 Rockville Centre, New York, United States

Hartford Healthcare (Data Collection Only); 🇺🇸 Hartford, Connecticut, United States

Memorial Sloan Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States