DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements
Joshua Palmer
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria: Subject must meet all of the following applicable inclusion criteria to participate in this study: 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. Histo…
Interventions
- DrugAlectinib
600mg taken orally, twice daily for 25 Cycles Cycle = 4 weeks (28 days)
- RadiationStereotactic Radiosurgery
SRS dose varies by brain met size and location
Locations (3)
- Stanford UniversityStanford, California
- University of Colorado Cancer CenterAurora, Colorado
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio