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A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

NCT03596866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-09-12

Study results available
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Summary

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.

Conditions

  • ALK+ Advanced NSCLC

Interventions

DRUG

Brigatinib

Brigatinib Tablets.

DRUG

Alectinib

Alectinib Capsules.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-19
Primary Completion
2024-02-27
Completion
2024-09-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Canada
  • Chile
  • China
  • Croatia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Mexico
  • Romania
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596866 on ClinicalTrials.gov