Study on Stereotactic Radiosurgery and Standard Treatment for Lung Cancer Spread to the Brain

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT06741085

This clinical trial is exploring whether adding stereotactic radiosurgery (SRS) to standard treatment with osimertinib is more effective for treating brain metastases in people with non-small cell lung cancer (NSCLC) than using osimertinib alone. The study also examines how this treatment affects participants' quality of life through questionnaires.

Patient Parameters

Program Overview

The purpose of this study is to determine if using stereotactic radiosurgery (SRS) in addition to the standard treatment with osimertinib can better treat brain metastases in people with non-small cell lung cancer (NSCLC) that has spread to the brain. Researchers will also assess how this treatment impacts the quality of life of participants by having them fill out questionnaires.

Description

Participants in this study will receive standard care treatment, which includes osimertinib, a medication approved for targeting specific mutations in lung cancer that has spread to the brain. The study will compare the effects of adding stereotactic radiosurgery (SRS) to this treatment against using osimertinib alone. The goal is to see if the combination can better control brain metastases and improve quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have non-small cell lung cancer (NSCLC) with a specific EGFR mutation confirmed by the study center.
  • Have at least one brain metastasis that is 1 cm or larger, visible on scans before starting osimertinib.
  • Either have not started osimertinib or have started it within the last 3 months, with records of the start date and scans before starting the medication.

Exclusion Criteria

  • Cannot undergo an MRI with contrast.
  • Have had previous radiation treatment to the brain.
  • Have signs of cancer in the brain's protective layers (leptomeningeal disease) on MRI or spinal fluid tests, if done.
  • Have neurological symptoms or brain lesions needing immediate SRS treatment.
  • Have active blood cancers or another type of cancer known to spread to the brain.
  • Have had surgery to remove brain metastases unless there are still untreated brain metastases that meet size criteria.
  • Are judged by the study doctor as unlikely to follow study procedures.
  • Are pregnant, breastfeeding, or able to become pregnant without using effective birth control during the study and for 3 months after the last treatment.

Randomization Inclusion Criteria:

  • Have detectable and stable brain metastases on scans, showing remaining disease.

Randomization Exclusion Criteria:

  • Have worsening disease with multiple lesions needing a change in treatment.
  • Have brain metastases that cannot be safely treated with SRS.
  • Have no visible brain metastases (complete response).
  • Have more than 20 visible brain metastases after initial treatment with osimertinib, although there is no limit on the number of metastases before starting osimertinib.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (All Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (All Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (All Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (All Protocol Activities)11553Rockville CentreNew York

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