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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

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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.

DURABLE Trial 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

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

~460

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,087 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being recruited for this ongoing medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively seeking eligible individuals. The trial was initially posted on January 1st, 2024 and was last updated on January 4th, 2024. The study aims to enroll a total of 56 patients across one location."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is currently seeking eligible participants. The initial posting of the trial occurred on January 1st, 2024, and it was last updated on January 4th, 2024. This study aims to enroll a total of 56 patients from one designated site."

Answered by AI

What is the primary goal of conducting this medical study?

"The primary objective of this study, which will be observed over a span of approximately 12 months, is to assess the safety and feasibility in Phase 1b. Secondary objectives include evaluating Extracranial PFS (Progression-Free Survival) defined as the period from randomization until progression according to RECIST v1.1 criteria, determining Intracranial duration of response (icDOR) defined as the time from meeting CR or PR criteria per RANO-BM to an icPFS event occurrence, and assessing Safety and Tolerability by measuring adverse events frequency and severity based on CTCAE v5.0 guidelines"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Joshua Palmer 2024. "Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05987644.