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Alectinib ± Upfront Radiosurgery

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

  • RegistryNCT05987644
  • PhasePhase 1/2
  • StatusRecruiting
  • ConditionALK-Positive Lung Cancer With Brain Metastases
  • SponsorJoshua Palmer
How Alectinib ± Radiosurgery works1 min

The drug

What is being tested.

600mg taken orally, twice daily for 25 Cycles Cycle = 4 weeks (28 days)

SRS dose varies by brain met size and location

The study

How the trial runs.

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.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • 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.
  • ECOG Performance Status of ≤ 2 within 14 days prior to registration.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

For you, or someone you love

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How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

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