Brigatinib + Bevacizumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Dr. Victoria M. Villaflor, MD | Duarte ...

Overseen byVictoria Villaflor, Dr

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests brigatinib and bevacizumab in patients with a specific type of lung cancer that has spread or come back. Brigatinib blocks growth signals in cancer cells, while bevacizumab blocks the tumor's blood supply. The goal is to find the best dose and see how well these drugs work together.

Eligibility Criteria

This trial is for adults with ALK-rearranged non-small cell lung cancer that's advanced, spread elsewhere, or returned after treatment. They must have tried ALK-targeted therapy before and still show signs of the disease. Participants need to be in fairly good health overall, understand the study, agree to use contraception, and not have had certain treatments or surgeries recently.

Inclusion Criteria

My cancer progressed despite treatment targeting ALK.

Patients must meet criteria for appropriate contraception

My organs and bone marrow are functioning well.

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Exclusion Criteria

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

I have not had a recent pulmonary embolism or untreated deep vein thrombosis in the last 3 months.

I don't have any other cancers that are likely to worsen within a year.

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Treatment Details

Interventions

Bevacizumab (Monoclonal Antibodies)
Brigatinib (Tyrosine Kinase Inhibitor)

Trial OverviewResearchers are testing brigatinib combined with bevacizumab to see how well they work together against this type of lung cancer. Brigatinib targets enzymes needed by cancer cells to grow while bevacizumab aims to stop these cells from spreading.

Participant Groups

1Treatment groups

Experimental Treatment

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

Patients receive brigatinib PO QD on days 1-28 of cycle 1 and days 1-21 of subsequent cycles. Patients also receive bevacizumab IV on day 8 of cycle 1 and day 1 of subsequent cycles. Starting cycle 2, cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺 Approved in European Union as Avastin for: