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ALK Inhibitor

Phase 2: Arm A for Lung Cancer (DURABLE Trial)

Phase 1 & 2
Recruiting
Led By Joshua D Palmer, MD
Research Sponsored by Joshua Palmer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological or cytological confirmation of Stage IV (per AJCC 8th edition) non-small cell lung cancer (NSCLC).
1. Subjects must have 1-15 intracranial metastases less than 3 cm with only 1 lesion more than 2 cm.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24 months
Awards & highlights

DURABLE Trial Summary

This trial will have two parts, Phase 1b and Phase 2. The Phase 1b will happen first, followed by Phase 2. Each cycle of treatment will last 28 days

Who is the study for?
This trial is for adults over 18 with Stage IV non-small cell lung cancer (NSCLC) and ALK rearrangements. They must have 1-15 brain metastases, be asymptomatic or minimally symptomatic, and not need surgery within 28 days of starting the study. Participants should speak English as their first language and agree to delay radiation therapy.Check my eligibility
What is being tested?
The trial tests Alectinib, an oral drug taken twice daily for up to two years. Phase 1b participants receive only Alectinib; in Phase 2, one group continues with just Alectinib while another receives Stereotactic Radiosurgery (SRS) plus Alectinib.See study design
What are the potential side effects?
Alectinib may cause side effects like fatigue, constipation, swelling in parts of the body, liver issues, muscle pain, light sensitivity rash or sunburns when exposed to sunlight or sunlamps.

DURABLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is confirmed to be at stage IV.
Select...
I have 1-15 brain metastases, with only one larger than 2 cm but no larger than 3 cm.
Select...
My cancer has a confirmed ALK rearrangement.
Select...
I have more than 15 brain tumors, each smaller than 3 cm.

DURABLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Safety and Feasibility
Phase 2: Neurological status and control of CNS disease at 12 months compared to alectinib plus SRS in patients with ≤15 CNS metastases
Secondary outcome measures
Assess Overall survival (OS)
Cognitive decline at 12 and 24 months
Extracranial PFS
+6 more

DURABLE Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase 2: Arm BExperimental Treatment2 Interventions
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 II: Phase 2: Arm AExperimental Treatment1 Intervention
600mg alectinib taken orally twice daily
Group III: Phase 1b: ExperimentalExperimental Treatment1 Intervention
600mg alectinib taken orally twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alectinib
2015
Completed Phase 3
~2400
Stereotactic Radiosurgery
2016
Completed Phase 2
~490

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
567,975 Total Patients Enrolled
Joshua PalmerLead Sponsor
Joshua D Palmer, MDPrincipal InvestigatorThe Ohio State University Comprehensive Cancer Center
1 Previous Clinical Trials
47 Total Patients Enrolled
~37 spots leftby Jan 2026
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