BO28984 Alectinib versus Crizotinib in advanced NSCLC
Research type
Research Study
Full title
A randomised, multicentre, phase III, open-label study of alectinib versus crizotinib in treatment-naive anaplastic lymphoma kinase-positive advanced non-small cell lung cancer patients
IRAS ID
148409
Contact name
Martin Forster
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2013-004133-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 14 days
Research summary
Non-small cell lung cancer (NSCLC) is one of two major types of lung cancer and accounts for approximately 85% of all lung cancer cases. The expected 5 year survival rate for all patients in whom lung cancer is diagnosed is 16.3%. Approximately 5% of NSCLC case are anaplastic lymphoma kinase (ALK) positive; this fusion protein affects ALK gene expression and contributes to increased cellular growth and tumour survival.
Currently crizotinib is the only approved therapy for ALK-positive NSCLC. Clinical benefit has been observed with crizotinib, however relapse of disease is frequently seen. This is due to the development of resistance by the tumour or central nervous system relapse. There remains an unmet medical need to find and develop new generations of ALK inhibitors, in order to overcome the limitations of crizotinib.
The study aims to evaluate the safety and efficacy of alectinib in ALK positive patients who have not received treatment for their advanced disease. This will be compared to crizotinib.
A total of approximately 286 patients will be enrolled on to the study globally. There will be two treatment groups: patients will take either alectinib or crizotinib every day, twice a day by mouth. Which treatment a patient receives will be decided by chance by a computer, not by a doctor. 143 patients will receive alectinib and 143 patients will receive crizotinib. Patients will not receive both.
Drug treatment will continue until a patients' disease progresses (worsens), there is unacceptable toxicity (side effects) or the patient or study doctor decide to stop treatment. The study will run for approximately 4 to 5 years.
In the UK it is anticipated that 8 patients will be enrolled at 4 participating study centres.
REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0032
Date of REC Opinion
9 Feb 2015
REC opinion
Further Information Favourable Opinion