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Tyrosine Kinase Inhibitor

LCT + Brigatinib for Lung Cancer

Phase 1

Waitlist Available

Led By Saumil Gandhi, 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

Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)

Male patients must meet specific criteria regarding effective barrier contraception or abstinence

Must not have

Previously received more than 1 regimen of chemotherapy or immunotherapy for locally advanced or metastatic disease

Symptomatic CNS metastasis or asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of LCT and brigatinib on patients with stage IV or recurrent non-small cell lung cancer.

Who is the study for?

This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) that have a specific ALK gene change. They must be healthy enough based on blood tests, not pregnant, and willing to use contraception. People can't join if they've had certain other treatments for NSCLC, uncontrolled health issues like heart disease or high blood pressure, active infections, or HIV.

What is being tested?

The study is testing the combination of Local Consolidative Therapy (LCT), which includes surgery and/or radiation to remove remaining tumor cells after initial treatment, with a drug called Brigatinib that blocks enzymes tumors need to grow.

What are the potential side effects?

Possible side effects include reactions related to organ function from LCT such as pain or fatigue and those from Brigatinib like nausea, diarrhea, elevated blood pressure, changes in vision, muscle pain and potential risks to liver function.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is at stage IV or has come back and cannot be treated with combined therapies.

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I am a male and will use effective contraception or practice abstinence.

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

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

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

Exclusion Criteria

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

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I have had more than one treatment for my advanced cancer.

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I have brain metastases needing more steroids recently.

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

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I have lung conditions like interstitial disease or pneumonitis.

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I am experiencing pressure on my spinal cord.

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

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I have a serious heart condition that is not under control.

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I have been diagnosed with HIV.

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My high blood pressure is not under control.

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I currently have an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Secondary study objectives

Overall survival (OS)

Progression-free survival (PFS)

Time to progression of non-local consolidative therapy (LCT) lesion

Other study objectives

Potential prognostic and predictive biomarkers

Time to appearance of new metastatic lesion(s) (TANM)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (brigatinib, LCT)Experimental Treatment2 Interventions

Patients receive brigatinib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo LCT for up to 3 weeks in the absence of disease progression or unacceptable toxicity. Within 7 days after completion of LCT, patients receive brigatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brigatinib

2019

Completed Phase 3

~1240

0 / 15Eligibility criteria met