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

Part of paid clinical trials in Stanford, California.

Sponsor
Joshua Palmer
Study ID
NCT05987644
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alectinib — DRUG
    600mg taken orally, twice daily for 25 Cycles Cycle = 4 weeks (28 days)
  • Stereotactic Radiosurgery — RADIATION
    SRS dose varies by brain met size and location

Study Details

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.

Key Dates

Start date
Mar 7, 2024
Status verified
Apr 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Experimental
    600mg alectinib taken orally twice daily
  • Experimental: Phase 2: Arm A
    600mg alectinib taken orally twice daily
  • Experimental: Phase 2: Arm B
    Subjects will receive SRS prior to taking alectinib. 24 hours after, but no more than 7 days after last radiation dose, alectinib should be taken at 600mg orally twice daily

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Brittany Johnson
[email protected]
Nathaniel Myall, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado Cancer CenterAuroraColorado80045
Brian Kavanagh, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Brian Spahnie
[email protected]
Joshua Palmer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Stanford University· Stanford, CAUniversity of Colorado Cancer Center· Aurora, COOhio State University Comprehensive Cancer Center· Columbus, OH

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