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

Completed · Phase 2

Conditions studied: ALK-positive Advanced NSCLC

In brief

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.

Key facts

Study ID

NCT03535740

Run by

Ariad Pharmaceuticals

People needed

103

Starts

2019-01-31

Expected to finish

2024-08-21

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Must meet both of the following 2 criteria:
• 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.)
• Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression.
• Had progressive disease (PD) while on alectinib or ceritinib
• Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
• Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
• 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.
• Have a life expectancy of ≥3 months.

You may not qualify if…

• Had received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib.
• Had received both alectinib and ceritinib.
• Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease.
• 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.
• Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
• Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib.
• Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.
• Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.

Where it is running

• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• USOR - Rocky Mountain Cancer Centers - Pueblo — Pueblo, Colorado, United States
• Florida Hospital Medical Group — Orlando, Florida, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Levine Cancer Institute - Southpark — Charlotte, North Carolina, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• USOR - Virginia Cancer Specialists - Fairfax Office — Fairfax, Virginia, United States
• Saint Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
• Peninsula & South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• Klinikum Klagenfurt Am Worthersee — Klagenfurt, Carinthia, Austria
• Krankenhaus Elisabethinen Linz — Linz, Upper Austria, Austria
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Tom Baker Cancer Center — Calgary, British Columbia, Canada
• Toronto University Health Network — Toronto, Ontario, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• Jilin Provincial Cancer Hospital (Changchun Cancer Hospital) — Changchun, Jilin, China
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
• University of California Irvine Health Chao Family Comprehensive Cancer Center — Orange, California, United States

Full record on ClinicalTrials.gov

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