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ALTA-2: Phase II study of brigatinib in patients with ALK-positive, advanced non-small-cell lung cancer who progressed on alectinib or ceritinib
- Source :
- Future Oncology. 17:1709-1719
- Publication Year :
- 2021
- Publisher :
- Future Medicine Ltd, 2021.
-
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.
- Subjects :
- Adult
Male
Alectinib
Oncology
Cancer Research
medicine.medical_specialty
Lung Neoplasms
Brigatinib
Carbazoles
Drug Administration Schedule
03 medical and health sciences
Clinical Trials, Phase II as Topic
Organophosphorus Compounds
0302 clinical medicine
Piperidines
Carcinoma, Non-Small-Cell Lung
hemic and lymphatic diseases
Internal medicine
medicine
Humans
Anaplastic lymphoma kinase
Anaplastic Lymphoma Kinase
Sulfones
030212 general & internal medicine
Lung cancer
Protein Kinase Inhibitors
Response Evaluation Criteria in Solid Tumors
Ceritinib
Crizotinib
business.industry
General Medicine
Middle Aged
medicine.disease
Progression-Free Survival
respiratory tract diseases
Pyrimidines
Drug Resistance, Neoplasm
030220 oncology & carcinogenesis
Disease Progression
Quality of Life
Female
business
Progressive disease
medicine.drug
Subjects
Details
- ISSN :
- 17448301 and 14796694
- Volume :
- 17
- Database :
- OpenAIRE
- Journal :
- Future Oncology
- Accession number :
- edsair.doi.dedup.....410421caba11711a7a69187426e91dbf