GO28753 Anti-PDL1 in NSCLC
Research type
Research Study
Full title
A Phase II, Open-Label, Multicenter, Randomized 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 Platinum Failure
IRAS ID
126769
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2013-001142-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 5 months, 10 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. 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.
This study aims to discover whether MPDL3280A is safe and effective in locally advanced or metastatic NSCLC patients who have previously received platinum-containing chemotherapy for their disease. This will be compared to docetaxel, a drug known as a taxane that is currently available to treat NSCLC.
A total of approximately 180 patients will be recruited into the study study globally. There will be two treatment groups; patients will receive either MPDL3280A or docetaxel as an infusion once every three weeks. Which treatment a patient receives will be decided by chance by a computer, not by a doctor. Ninety patients will receive MPDL3280A and ninety patients will receive docetaxel. 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 decides to stop treatment. If patients' are assigned to receive MPDL3280A and their diseases worsens (occassional initial tumour 'flare' is seen), they may be eligible to receive additional MPDL3280A treatment, providing they meet certain criteria. This is not an option for those patients who receive docetaxel. The study will run for approximately 4 to 5 years.
In the UK it is expected that 9 patients will be enrolled at 4 participating study centres.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1352
Date of REC Opinion
24 Sep 2013
REC opinion
Favourable Opinion