RecruitingPhase 1/2

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

United States56 participantsStarted 2024-03-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Histological or cytological confirmation of Stage IV (per AJCC 8th edition) non-small cell lung cancer (NSCLC).
✓. At least one intracranial metastasis on MRI imaging.
✓. Confirmation of positive ALK rearrangement per local standard of care testing.
✓. All subjects must have brain metastases and be either asymptomatic or minimally symptomatic per investigator discretion without plan for surgical intervention within 28 days of study start. Patients with neurological symptoms that are controlled with dose of corticosteroids or anti-epileptic medications are eligible. Patients with asymptomatic leptomeningeal disease may be eligible for trial providing they meet all other eligibility criteria.

Exclusion criteria

What they're measuring

Phase 2: Neurological status and control of CNS disease at 12 months compared to alectinib plus SRS in patients with ≤15 CNS metastases

Timeframe: 12 months

Phase 1b: Safety and Feasibility

Timeframe: 6 months

Trial details

NCT IDNCT05987644

SponsorJoshua Palmer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-28

Contact for this trial

Joshua D Palmer, MD

614-293-0871 joshua.palmer@osumc.edu

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