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ALK Inhibitor

Brain Radiotherapy 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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed to be at stage IV.

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I have 1-15 brain metastases, with only one larger than 2 cm but no larger than 3 cm.

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My cancer has a confirmed ALK rearrangement.

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I have more than 15 brain tumors, each smaller than 3 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Assess Overall survival (OS)

Cognitive decline at 12 and 24 months

Extracranial PFS

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2019

Completed Phase 3

~2810