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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

NCT05987644 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Joshua Palmer

    lead OTHER

Principal Investigators

  • Joshua D Palmer, MD · The Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2028-02-28
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05987644 on ClinicalTrials.gov