Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days. Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib. A maximum of 25 cycles (2 years) of alectinib may be administered on study.

Trial Details

NCT ID
NCT05987644
Phase
PHASE1 / PHASE2
Sponsor
Joshua Palmer
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Alectinib
  • Stereotactic Radiosurgery
Locations (sample)
  • Stanford, California, United States|37.42411,-122.16608
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Subject must meet all of the following applicable inclusion criteria to participate in this study:
  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be…
  • Age ≥ 18 years at the time of consent.
  • Fluent English skills with comprehensive/speaking skills equal to those of a native English speaker as assessed by the site investigator.

For full eligibility, visit ClinicalTrials.gov.

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