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A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

NCT03535740 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-07-31

Study results available
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Summary

The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors \[RECIST\]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.

Conditions

  • ALK-positive Advanced NSCLC

Interventions

DRUG

Brigatinib

Brigatinib Tablets

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Ariad Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2020-09-30
Completion
2024-08-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Spain
  • Sweden
  • Taiwan

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 NCT03535740 on ClinicalTrials.gov