GO28915 - MPDL3280A or Docetaxel in Patients with NSCLC
Research type
Research Study
Full title
A PHASE III, OPEN-LABEL, MULTICENTRE, RANDOMISED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY
IRAS ID
150892
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2013-003331-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 9 months, 8 days
Research summary
Lung cancer is the leading cause of cancer deaths worldwide. 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. There is a poor overall 5 year survival rate for advanced NSCLC at approximately 2-4%. There remains an unmet medical need to find new therapies for this disease as current treatments aim to maximise patients’ survival and quality of life.
The aim of this study is to compare MPDL3280A with docetaxel, in terms of safety and efficacy, in participants with locally advanced or metastatic NSCLC.
A total of approximately 850 participants will be recruited into this study globally. All participants will receive MPDL3280A or docetaxel as an infusion once every 3 weeks.
If assigned to MPDL3280A, you will receive a maximum of 16 cycles (or 12 months, whichever occurs first). Participants may be eligible for re-treatment with MPDL3280A if their disease worsens after completing the initial treatment phase, providing they meet certain criteria.
If assigned to docetaxel, you will receive study medication until your disease worsens.
In the UK it is expected that 40 participants will be enrolled at 8 participating study centres.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0882
Date of REC Opinion
17 Jun 2014
REC opinion
Favourable Opinion