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

NCT ID: NCT05987644

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2027-01-31

Brief 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

Lung Cancer; NSCLC; Brain Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b: Experimental

600mg alectinib taken orally twice daily

Group Type: EXPERIMENTAL

Alectinib

Intervention Type: DRUG

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

Phase 2: Arm A

600mg alectinib taken orally twice daily

Group Type: EXPERIMENTAL

Alectinib

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Alectinib

Intervention Type: DRUG

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

Stereotactic Radiosurgery

Intervention Type: RADIATION

SRS dose varies by brain met size and location

Interventions

Alectinib

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

Intervention Type: DRUG

Stereotactic Radiosurgery

SRS dose varies by brain met size and location

Intervention Type: RADIATION

Other Intervention Names

SRS

Eligibility Criteria

Inclusion Criteria

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. 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 registration.

10. Prior non-ALK directed therapy for metastatic disease is permitted. Patients who have received prior neoadjuvant or 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. Acute viral, autoimmune, alcoholic, or other types of acute hepatitis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Joshua Palmer

OTHER

Sponsor Role: lead

Responsible Party

Joshua Palmer

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joshua D Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University Comprehensive Cancer Center

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status: RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joshua D Palmer, MD

Role: CONTACT

joshua.palmer@osumc.edu

614-293-0871

Amber Ryba

Role: CONTACT

aryba@hoosiercancer.org

317-634-5842 ext. 13

Facility Contacts

Brittany Johnson

Role: primary

brittan5@stanford.edu

Robyn Swing

Role: primary

robyn.swing@cuanschutz.edu

Brian Spahnie

Role: primary

brian.spahnie@osumc.edu

Other Identifiers

HCRN-LUN21-534

Identifier Type: -

Identifier Source: org_study_id