LCT + Brigatinib for Lung Cancer

Recruiting in Palo Alto (17 mi)

Saumil Gandhi | MD Anderson Cancer Center

Overseen bySaumil Gandhi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This early phase I trial studies the side effects and how well local consolidative therapy (LCT) and brigatinib works in treating patients with non-small cell lung cancer that is stage IV or has come back (recurrent). Giving LCT, such as surgery and/or radiation, after initial treatment may kill any remaining tumor cells. Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving LCT and brigatinib may work better in treating patients with non-small cell lung cancer.

Research Team

Saumil Gandhi, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Your heart's electrical activity is normal, as shown on a recent ECG test.

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

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Exclusion Criteria

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

I have brain metastases needing more steroids recently.

I have lung conditions like interstitial disease or pneumonitis.

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Treatment Details

Interventions

Brigatinib (Tyrosine Kinase Inhibitor)
Local Consolidation Therapy (Radiation)

Trial OverviewThe 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.

Participant Groups

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.