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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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. First language must be English. 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 6 weeks prior to radiation. 10. Prior non-ALK directed therapy for metastatic disease is permitted. Patients who have received prior neoadjuvant, 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. 11. Documentation of consultation with a radiation oncologist confirming agreement to delay radiation therapy. 12. Demonstrate adequate organ function as defined in the protocol. All screening labs to be obtained within 14 days prior to registration. 13. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. See protocol for definition of childbearing potential. 14. Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in the protocol. 15. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. 16. Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. 17. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

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). 4. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial. 5. Treatment with any investigational drug within 28 days prior to registration. 6. History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer. 7. Acute viral, autoimmune, alcoholic, or other types of acute hepatitis.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05987644
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Joshua Palmer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joshua D Palmer, MD
Principal Investigator Affiliation	The Ohio State University Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Cancer, NSCLC, Brain Metastases

Arms & Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Stanford, California

Status

Recruiting

Address

Stanford University

Stanford, California, 94305

Site Contact

Brittany Johnson

[email protected]

614-293-0871

Columbus, Ohio

Status