Lead Investigator: Xue Yang, Beijing Cancer Hospital
Title of Proposal Research: Crizotinib followed by alectinib vs alectinib alone: analysis of treatment-naïve patients with non-small cell lung cancer (NSCLC) harboring anaplastic lymphoma kinase (ALK) -rearrangement
Vivli Data Request: 7873
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Lung cancer ranks among the most common types of cancer in North America, with an estimated incidence of 222,500 in the US and 28,600 in Canada in 2017. Lung cancer is the leading cause of death among all cancer-releated deaths worldwide. About 85% of patients with lung cancer have non-small cell lung cancer (NSCLC), with 5% of patients harbouring rearrangements in the anaplastic lymphoma kinase (ALK) gene. The ALK gene provides instructions for making a protein called ALK receptor tyrosine kinase, which is part of a family of proteins called receptor tyrosine kinases (RTKs). The presence of mutations or rearrangements in the anaplastic lymphoma kinase (ALK) gene renders the cancer sensitive to tyrosine kinase inhibitors. Tyrosine kinase inhibitors (TKIs) are a type of targeted therapy. A targeted therapy identifies and attacks specific types of cancer cells while causing less damage to normal cells. It is very common for this type of cancer to be missed until it is at an advanced stage.
There is limited data about alectinib vs crizotinib followed by alectinib in ALK-inhibitor naïve patients with NSCLC in the real-world setting especially in Chinese patients. Crizotinib is the first-in-class drug used to treat ALK-positive tumors. Alectinib is a second-generation, highly selective, central nervous system (CNS)-active ALK inhibitor with activity against several ALK mutations reported to confer resistance to crizotinib. As compared with crizotinib, alectinib showed superior efficacy and lower toxicity in primary treatment of ALK-positive NSCLC in ALEX study.
Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02075840
Sponsor ID: BO28984