Summary

for people ages 18 years and up (full criteria)
at UC Irvine
study started
estimated completion:

Description

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.

Official Title

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

Details

The drug being tested in this study is called brigatinib (AP26113). Brigatinib is being tested to treat people who have anaplastic lymphoma kinase-positive (ALK+), advanced non-small-cell lung cancer (NSCLC).

The study will enroll approximately 103 patients. Participants will be assigned to the treatment group:

• Brigatinib

All participants will be asked to take brigatinib 90 mg tablet in lead-in period for 7 days, followed by brigatinib 180 mg at the same time each day throughout the study.

This multicenter trial will be conducted worldwide. The overall time to participate in this study is approximately 5 years, but the total sample size and study duration may be adjusted according to preliminary data from interim analysis. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

Keywords

ALK-positive Advanced NSCLC Drug Therapy Carcinoma, Non-Small-Cell Lung Ceritinib Brigatinib

Eligibility

You can join if…

Open to people ages 18 years and up

  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:
  3. 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.)
  4. Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib,ceritinib, crizotinib) for at least 12 weeks before progression.
  5. Had progressive disease (PD) while on alectinib or ceritinib
  6. Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
  7. Have at least 1 measurable lesion per response evaluation criteria in solid tumors(RECIST) version 1.1 as assessed by the investigator.
  8. 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.

  1. Have a life expectancy of ≥3 months.

You CAN'T join if...

  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.

Locations

  • University of California Irvine Health Chao Family Comprehensive Cancer Center not yet accepting patients
    Orange California 92868-3298 United States
  • The Oncology Institute of Hope and Innovation accepting new patients
    Whittier California 90602 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Ariad Pharmaceuticals
ID
NCT03535740
Phase
Phase 2
Study Type
Interventional
Last Updated