Brigatinib vs Alectinib for Non-Small Cell Lung Cancer
(ALTA-3 Trial)

Recruiting in Palo Alto (17 mi)

+114 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Takeda

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: * Brigatinib tablets * Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.

Eligibility Criteria

Adults with advanced non-small-cell lung cancer (NSCLC) who have good performance status, measurable tumors, and adequate organ function can join. They shouldn't have had certain recent treatments or uncontrolled illnesses like heart disease, infections, or brain metastases that cause symptoms.

Inclusion Criteria

Suitable venous access for study-required blood sampling (that is, including pharmacokinetic [PK] and laboratory safety tests)

Must meet one of the following criteria:

You have at least one visible or measurable lesion according to specific guidelines.

+11 more

Exclusion Criteria

I have a history of serious irregular heartbeats.

I haven't taken experimental cancer drugs in the last 14 days or more.

I have had severe heart failure in the last 6 months.

+25 more

Participant Groups

The trial is testing whether brigatinib tablets are more effective than alectinib capsules in stopping tumor growth in NSCLC patients. Participants will be randomly assigned to one of the two drugs and take it daily until their condition worsens or they experience significant side effects.

2Treatment groups

Experimental Treatment

Active Control

Group I: BrigatinibExperimental Treatment1 Intervention

Participants were administered brigatinib 90 milligrams (mg), tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator, or intolerable toxicity, or up to 33.8 months.

Group II: AlectinibActive Control1 Intervention

Participants were administered alectinib 600 mg, capsules, orally, twice daily (BID) until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity, or up to 33.8 months.

Alectinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Alecensa for: