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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Lung Cancer Metastatic; Brain Metastases, Adult; Small-cell Lung Cancer; Brain Metastases; Lung Cancer; Small Cell Lung Carcinoma

Treatments: Procedure: Cerebrospinal fluid collection; Radiation: Stereotactic Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05419076

22-133

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Participants with small cell lung cancer with brain metastases

Experimental group

Description:

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.

Treatment:

Radiation: Stereotactic Radiosurgery

Procedure: Cerebrospinal fluid collection