Comparison of X-396 to Crizotinib in ALK Positive NSCLC Patients
Research type
Research Study
Full title
XALT3: Phase 3 Randomized Study Comparing X-396 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer(NSCLC) Patients
IRAS ID
211361
Contact name
Vance Oertel
Contact email
Sponsor organisation
Xcovery Holding Company, LLC
Eudract number
2015-004147-40
Clinicaltrials.gov Identifier
111,695, IND Number; CANC 5371, CRN Reference
Duration of Study in the UK
4 years, 3 months, 31 days
Research summary
Xcovery Holding Company LLC is developing a new drug, X-396 for the treatment of patients with non small cell lung cancer (NSCLC). Patients will be tested for a gene mutation known as ALK and if they test positive, may be eligible to enter the study. A comparison will be made of the safety and effectiveness of X-396 to a marketed product, crizotinib in patients that have received up to one prior chemotherapy regimen. Patients 18 years and over will be invited to participate and it is planned to enrol up to 402 patients across 200 sites worldwide. Eligible patients will either be treated with 225mg X-396 given orally once daily or 250mg crizotinib given orally twice daily, each as single treatments on a 28 day schedule. Treatments will be allocated in a random manner (like the toss of a coin) in a ratio of 1:1 and it will be open-label (patients will know which treatment they have been allocated to). All patients will continue on their allocated treatment until their disease progresses, or if discontinued due to unacceptable toxicity or a decision by the patient or the study doctor. A safety follow-up will then be performed 30 days after stopping treatment.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0369
Date of REC Opinion
12 Oct 2016
REC opinion
Further Information Favourable Opinion