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ALK Inhibitor

Brigatinib + Chemotherapy for Lung Cancer

Phase 2

Waitlist Available

Led By Yasir Y Elamin, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male patients must agree to practice effective barrier contraception or completely abstain from heterosexual intercourse

Female patients of childbearing potential must have a negative pregnancy test documented at time of screening

Must not have

Had major surgery within 30 days of enrollment

Ongoing or active infection, including the requirement for intravenous antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial aims to see if using brigatinib with either radiation or surgery, or with chemotherapy, can better control the disease compared to using brigatinib alone. The study will also look at the

Who is the study for?

This trial is for individuals with advanced non-small cell lung cancer that tests positive for a change in the ALK gene. Participants should not have received brigatinib previously and must be fit enough for chemotherapy or local treatments like radiotherapy or surgery.

What is being tested?

The study is testing whether taking brigatinib along with either local consolidation therapy (like radiation or surgery) or chemotherapy drugs pemetrexed and carboplatin can better control lung cancer than just brigatinib alone.

What are the potential side effects?

Possible side effects include nausea, fatigue, high blood pressure, vision changes from brigatinib; numbness, kidney issues from pemetrexed; and hair loss, low blood counts from carboplatin.

Eligibility Criteria

Inclusion Criteria

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

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I will use effective contraception or abstain from sex.

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I am a woman who can have children and have a negative pregnancy test.

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My lung cancer is at stage IV or has come back and can't be treated with surgery and other combined treatments.

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My cancer has a specific genetic change known as ALK rearrangement.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 30 days.

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I do not have any current infections requiring IV antibiotics.

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I am not taking any other cancer treatments while in this study.

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I have previously been treated with a type of cancer therapy known as TKI.

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I've had more than one round of chemo, with or without immunotherapy, for advanced cancer.

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I am currently experiencing spinal cord compression.

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I have lung conditions like interstitial disease or pneumonitis.

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I have a condition that affects how my body absorbs medication taken by mouth.

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I do not have serious heart problems that are not under control.

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I have not had a stroke in the last 6 months.

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I have no allergies to brigatinib, carboplatin, pemetrexed, or similar drugs.

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I have been diagnosed with HIV.

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I have brain metastases that are causing symptoms or require more steroids recently.

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My blood pressure is not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Group I: Brigatinib MonotherapyExperimental Treatment1 Intervention

Given by mouth

Group II: Brigatinib + Local Consolidation Therapy (LCT)Experimental Treatment1 Intervention

Given by vein

Group III: Brigatinib + Carboplatin + PemetrexedExperimental Treatment3 Interventions

Given by vein

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brigatinib

2018

Completed Phase 3

~890

Pemetrexed

2014

Completed Phase 3

~5550

Carboplatin

2014

Completed Phase 3

~6120

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,533 Total Patients Enrolled

Yasir Y Elamin, MDPrincipal InvestigatorMD Anderson Cancer Cetner

2 Previous Clinical Trials

49 Total Patients Enrolled

~112 spots leftby Dec 2029

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