A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

Titre officiel

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®)

Sommaire:

L’objectif de cette étude est de comparer l’efficacité du brigatinib à celle de l’alectinib chez des participants atteints d’un cancer du poumon non à petites cellules (CPNPC) localement avancé ou métastatique positif pour la kinase ALK dont la maladie a progressé pendant le traitement par le crizotinib comme le montre la survie sans progression (SSP) évaluée selon les critères d’évaluation de la réponse des tumeurs solides (RECIST, version 1.1).

Description de l'essai

Primary Outcome:

• PFS as Assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1

Secondary Outcome:

• Overall Survival (OS)
• PFS as Assessed by Investigator per RECIST v1.1
• Objective Response Rate (ORR) as Assessed by Investigator and BIRC per RECIST v1.1
• Duration of Response (DOR) as Assessed by Investigator and BIRC
• Time to Response as Assessed by Investigator and BIRC
• Intracranial Objective Response Rate (iORR) as Assessed by BIRC per Modified RECIST v1.1
• Intracranial Duration of Response (iDOR) as Assessed by the BIRC per Modified RECIST v1.1
• Time to Intracranial Disease Progression (iPD) as Assessed by BIRC per Modified RECIST v1.1
• 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
• HRQOL from EORTC QLQ- Lung Cancer (LC) 13

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:

• Brigatinib

• Alectinib All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study. This multi-centre trial will be conducted in the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, and 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.

Voir cet essai sur ClinicalTrials.gov