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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

Female patients must meet specific criteria regarding menopausal status, surgical sterility, or contraception use

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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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I am a woman who is either post-menopausal, surgically sterile, or using contraception.

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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 have not taken TKIs or have been on brigatinib for ≤ 8 weeks without my cancer getting worse.

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I am eligible for targeted therapy on at least one remaining cancer site.

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I am 18 years old or older.

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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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My blood and organ function tests are within normal ranges.

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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Overall survival (OS)

Progression-free survival (PFS)

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

Other outcome measures

Potential prognostic and predictive biomarkers

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

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

2018

Completed Phase 3

~890

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,746 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,118 Total Patients Enrolled

Saumil Gandhi, MDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Brigatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03707938 — Phase 1

Lung Cancer Research Study Groups: Treatment (brigatinib, LCT)

Lung Cancer Clinical Trial 2023: Brigatinib Highlights & Side Effects. Trial Name: NCT03707938 — Phase 1

Brigatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03707938 — Phase 1

Frequently Asked Questions

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

Is Local Consolidation Therapy a viable method for protecting people's wellbeing?

"As a Phase 1 trial, Local Consolidation Therapy has limited efficacy and safety data. This resulted in it receiving an overall score of 1 from Power's team evaluation."

Answered by AI

Has Local Consolidation Therapy been explored in other research experiments?

"Currently, 11 clinical trials are exploring the effects of Local Consolidation Therapy with one study in phase 3. Although many experiments for this therapy occur in Goyang-si and Gyeonggi-do, there is a grand total of 796 medical centres conducting research on it."

Answered by AI

Are there any vacancies for volunteers in this experiment?

"As of now, this clinical trial is not seeking participants. The first posting was recorded on December 18th 2018 and the most recent alteration occured on November 2nd 20202. However, there are 4276 studies actively recruiting patients with malignant neoplasms as well as 11 trials for Local Consolidation Therapy that require volunteers."

Answered by AI

How many individuals have been recruited to participate in this clinical research?

"Unfortunately, this medical study is no longer admitting participants. It was first publicized on December 18th 2018 and the most recent update occurred November 2nd 2022. If you are looking for further studies to join, there are presently 4276 trials recruiting patients with malignant neoplasms plus 11 opportunities exploring Local Consolidation Therapy that still require volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

2018. "Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03707938.

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