BGB-A317-NSCL-001 - Phase 3 study in stage 3 subjects with NSCLC
Research type
Research Study
Full title
A Phase 3, randomized, blinded, placebo-controlled study of tislelizumab (BGB-A317) plus chemoradiotherapy followed by tislelizumab monotherapy in newly diagnosed, stage III subjects with locally advanced, unresectable non-small cell lung cancer
IRAS ID
249945
Contact name
Matthew Hatton
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2018-001132-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 30 days
Research summary
This is a clinical research study of the anti-PD-1 drug, tislelizumab (BGB-A317), in combination with chemoradiotherapy, in patients with stage III, locally advanced, non-small cell lung cancer (NSCLC) which cannot be surgically removed. \n\nNSCLC is the most common type of lung cancer, being up to 85% of all new cases. About a third of patients with NSCLC first see their doctor with locally advanced, stage III disease.\n\nTislelizumab is an antibody which works with the immune system. It targets a natural chemical produced by cancer cells called programmed cell death (PD-1). This is a protein which prevents the immune system from fighting the cancer. By blocking PD-1, tislelizumab allows the immune system to better fight the cancer.\n\nThis study will include approximately 33 patients from 11 planned sites in the UK. Approximately 840 patients will participate worldwide for a maximum of 5 years.\n\nParticipants will be assigned to one of three treatment groups at random. Neither the participant nor the study doctor will know which treatment group they will be placed in. The length of the treatment is approximately 14 months. The groups are:\n\n• Group 1: Two cycles of tislelizumab 200 mg given intravenously (into the vein) with chemotherapy and radiation, followed by tislelizumab alone\n• Group 2: Two cycles of placebo given intravenously with chemotherapy and radiation, followed by tislelizumab alone\n• Group 3: Two cycles of placebo given intravenously with chemotherapy and radiation, followed by placebo alone\n\nA cycle is 3 weeks (21 days).\n\nThe study involves procedures including: physical examinations, vital signs, blood and urine testing, tumour and possibly also lymph node biopsies, electrocardiogram (ECG), CT, MRI and PET scans, lung function tests, echocardiograms (ECHO) or MUGA (to measure heart function), and eye examinations. Some of these may only need to be done once at screening.\n\n\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0027
Date of REC Opinion
2 Apr 2019
REC opinion
Further Information Favourable Opinion