An Efficacy Study Comparing Brigatinib Versus Alectinib in Advanced Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small-Cell Lung Cancer (NSCLC) Participants Who Have Progressed on Crizotinib (ALTA-3)
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|ClinicalTrials.gov Identifier: NCT03596866|
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|ALK+ Advanced NSCLC||Drug: Brigatinib Drug: Alectinib||Phase 3|
The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to benefit people with ALK+ NSCLC.
The comparator drug is called alectinib. Alectinib has been demonstrated to benefit people with ALK+ NSCLC. Both drugs belong to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. Both drugs are taken by mouth. Both drugs are approved by the United States Food and Drug Administration (US FDA).
The study will enroll approximately 246 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups:
All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study.
This multi-center trial will be conducted the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Thailand. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||246 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)|
|Actual Study Start Date :||April 19, 2019|
|Estimated Primary Completion Date :||December 4, 2021|
|Estimated Study Completion Date :||December 5, 2022|
Brigatinib 90 milligram (mg), tablets, orally, once daily 7 days, followed by Brigatinib 180 mg, tablets, orally, once daily for until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.
Other Name: Alunbrig
Active Comparator: Alectinib
Alectinib 600 mg, capsules, orally twice daily until objective disease progression per RECIST version 1.1, as assessed by the investigator, or intolerable toxicity.
Other Name: Alecensa
- PFS as Assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1 [ Time Frame: Up to 5 years ]PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1, or death due to any cause, whichever occurs first, in the full analysis set. PFS will be censored for participants without documented disease progression or death at the last valid tumor response assessment.
- Time to Intracranial Progression (iPD) as Assessed by BIRC per Modified RECIST v1.1 [ Time Frame: Up to 5 years ]Time to iPD, as assessed by the BIRC, is defined as the time interval from the date of randomization until the first date at which intracranial disease progression is objectively documented via a modification of RECIST v1.1. Time to iPD will be censored for participants without documented intracranial disease progression at the last valid tumor response assessment.
- Overall Survival (OS) [ Time Frame: Up to 5 years ]OS is defined as the time interval from the date of randomization until death due to any cause in the full analysis set. It will be censored on the date of last contact for those participants who are alive.
- Objective Response Rate (ORR) as Assessed by Investigator and BIRC per RECIST v1.1 [ Time Frame: Up to 5 years ]ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), using RECIST v1.1 after the initiation of study treatment.
- Time to Response as Assessed by Investigator and BIRC [ Time Frame: Up to 5 years ]Time to response is defined as the time interval from randomization until the initial observation of CR or PR, as assessed by the investigator and BIRC, using RECIST v1.1. Time to response will be summarized using descriptive statistics in participants with confirmed objective response.
- Duration of Response (DOR) as Assessed by BIRC [ Time Frame: Up to 5 years ]DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the progressive disease (PD) is objectively documented or death, as assessed by the investigator and BIRC, using RECIST v1.1.
- Intracranial Objective Response Rate (iORR) as Assessed by BIRC per Modified RECIST v1.1 [ Time Frame: Up to 5 years ]iORR, as assessed by the BIRC, is defined as the percentage of the participants who have achieved CR or PR in the central nervous system (CNS) per a modification RECIST v1.1 after the initiation of study treatment in participant with CNS metastases at enrollment.
- Intracranial Duration of Response (iDOR) as Assessed by the BIRC per Modified RECIST v1.1 [ Time Frame: Up to 5 years ]iDOR, as assessed by the BIRC per modified RECIST v1.1, is defined as the time interval from the time that the measurement criteria are first met for CR or PR in the CNS (whichever is first recorded) until the first date that the PD in the CNS is objectively documented or death.
- Health-Related Quality of Life (HRQOL) from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 v3.0) Score [ Time Frame: First dose of study drug up to 30 days after last dose (approximately 9 years) ]EORTC QLQ-C30 incorporates 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better quality of life (QOL); for the symptom scales, lower scores represent better QOL.
- HRQOL from EORTC QLQ- Lung Cancer (LC) 13 [ Time Frame: First dose of study drug up to 30 days after last dose (approximately 9 years) ]HRQOL scores will be assessed with European Organization for Research and Treatment (EORTC), its lung cancer module QLQ-LC13. QLQ-LC13 contains 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596866
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
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|Study Director:||Medical Director Clinical Science||Ariad Pharmaceuticals|