CompletedPhase 2NCT03535740
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBrigatinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 31, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?80 U.S. locations

Locations may change over time.

Who runs it?Ariad Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Ariad Pharmaceuticals
Interventions being studied
Drug: Brigatinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a participant for curative therapy) or stage IV non-small-cell lung cancer (NSCLC). 2. Must meet both of the following 2 criteria: 1. Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test® approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non-FDA-approved local lab tests) and have provided tumor sample to the central laboratory. (Note: Central laboratory ALK rearrangement testing results are not required to be obtained before randomization.) 2. Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression. 3. Had progressive disease (PD) while on alectinib or ceritinib 4. Had alectinib or ceritinib as the most recent ALK inhibitor therapy. 5. Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator. 6. Had recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE), version 4.03, Grade \<=1. (Note: Treatment-related alopecia or peripheral neuropathy that are Grade \>1 are allowed if deemed irreversible.) and have adequate major organ functions. 7. Have a life expectancy of ≥3 months.

Reasons someone may not be able to joinExclusion criteria

1. Had received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib. 2. Had received both alectinib and ceritinib. 3. Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease. 4. Had symptomatic brain metastasis (parenchymal or leptomeningeal). Participants with asymptomatic brain metastasis or who have stable symptoms that did not require an increased dose of corticosteroids to control symptoms in the past 7 days before the first dose of brigatinib may be enrolled. 5. Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed. 6. Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib. 7. Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics. 8. Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California Irvine Health Chao Family Comprehensive Cancer CenterOrange, California
  • The Oncology Institute of Hope and InnovationWhittier, California
  • USOR - Rocky Mountain Cancer Centers - PuebloPueblo, Colorado
  • Florida Hospital Medical GroupOrlando, Florida
  • Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
  • Washington University School of MedicineSt Louis, Missouri
  • Levine Cancer Institute - SouthparkCharlotte, North Carolina
  • Providence Portland Medical CenterPortland, Oregon
  • Sarah Cannon Research InstituteNashville, Tennessee
  • USOR - Virginia Cancer Specialists - Fairfax OfficeFairfax, Virginia
  • Saint Vincent's Hospital MelbourneFitzroy, Victoria
  • Peninsula & South Eastern Haematology and Oncology GroupFrankston, Victoria

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2025. Always confirm current availability with the study team.

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