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Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT05987644•Joshua Palmer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Age ≥ 18 years at the time of consent.
•3. Fluent English skills with comprehensive/speaking skills equal to those of a native English speaker as assessed by the site investigator.
•4. ECOG Performance Status of ≤ 2 within 14 days prior to registration.
•5. Histological or cytological confirmation of Stage IV (per AJCC 8th edition) non-small cell lung cancer (NSCLC).
•6. At least one intracranial metastasis on MRI imaging.
•7. Confirmation of positive ALK rearrangement per local standard of care testing.
•8. 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.
•9. Subjects must be planning on therapy with alectinib. Alectinib may have been started up to 8 weeks prior to registration.
•10. Prior non-ALK directed therapy for metastatic disease is permitted. Patients who have received prior neoadjuvant or adjuvant chemotherapy, radiotherapy, immunotherapy (PD-1 or PD-L1 monoclonal antibodies) or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 3 months from registration since the last chemotherapy, radiotherapy, immunotherapy, or chemoradiotherapy cycle.
+7 more criteria

Exclusion Criteria

•Subjects meeting any of the criteria below may not participate in the study:
•1. Active infection requiring systemic therapy.
•2. Malabsorption syndrome or other condition that would interfere with enteral absorption
•3. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
•5. Treatment with any investigational drug within 28 days prior to registration.
•6. Acute viral, autoimmune, alcoholic, or other types of acute hepatitis.

Locations (3)

Stanford University

Stanford, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

March 7, 2024

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2027

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

Lung CancerNSCLCBrain Metastases

Interventions

Alectinib

DRUG

Stereotactic Radiosurgery

RADIATION

Contacts

Joshua D Palmer, MD

CONTACT

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

Amber Ryba

CONTACT

317-634-5842 aryba@hoosiercancer.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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