ALTA-2: Phase II study of brigatinib in patients with ALK-positive, advanced non-small-cell lung cancer who progressed on alectinib or ceritinib
Edward S Kim, Fabrice Barlesi, Tony Mok, Myung-Ju Ahn, Junwu Shen, Pingkuan Zhang, Sai-Hong Ignatius Ou, Edward S Kim, Fabrice Barlesi, Tony Mok, Myung-Ju Ahn, Junwu Shen, Pingkuan Zhang, Sai-Hong Ignatius Ou
Abstract
Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) have improved outcomes in ALK-rearranged (ALK+) non-small-cell lung cancer (NSCLC). However, almost all patients eventually develop progressive disease on first-line ALK TKIs (e.g., crizotinib, alectinib and ceritinib). Brigatinib, a second-generation ALK TKI, may show efficacy in alectinib- and ceritinib-refractory ALK+ NSCLC. We describe the rationale and design of ALTA-2, a Phase II study of brigatinib in patients with locally advanced/metastatic ALK+ NSCLC and documented progressive disease on alectinib or ceritinib. The primary end point is confirmed objective response rate per independent review committee using response evaluation criteria in solid tumors version 1.1. Secondary end points include duration of response, progression-free survival, overall survival, safety and health-related quality of life.
Trial registration: ClinicalTrials.gov NCT03535740.
Keywords: alectinib; anaplastic lymphoma kinase; brigatinib; ceritinib; neoplasm drug resistance; non-small-cell lung cancer; tyrosine kinase inhibitors.
Source: PubMed