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RECRUITING
NCT05987644
PHASE1/PHASE2

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-03-07

Completion Date

2029-02-28

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Alectinib

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

RADIATION

Stereotactic Radiosurgery

SRS dose varies by brain met size and location

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