GO28625 - Phase II study of MPDL3280A for non-small cell lung cancer
Research type
Research Study
Full title
A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
IRAS ID
133022
Contact name
Peter Schmid
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2013-000177-69
Clinicaltrials.gov Identifier
117296, IND number:
Duration of Study in the UK
1 years, 7 months, 15 days
Research summary
This study will recruit 130 patients, aged 18 and over, with a specific type of lung cancer called programmed cell death 1 ligand 1 (PD-L1). PD-L1 is a protein that binds to a receptor on the surface of immune cells and reduces the body’s immune responses. Of the patients in this study (130 in total), approximately 45 study participants will be patients who have not received prior chemotherapy for advanced disease and approximately 75 will be patients who have progressed during or following a platinum-based chemotherapy regimen for advanced disease. A separate cohort will enrol approximately 10 selected second-line (or greater) patients with previously treated brain metastases. Second-line means treatment that is given when initial treatment (first-line therapy) doesn’t work, or stops working. Brain metastases is cancer that has spread to the brain from another part of the body.
The study aims to find out how safe and effective a study drug called MPDL3280A is, in the treatment of this kind of disease. MPDL3280A is an engineered antibody that binds to PD-L1 and, by doing so, enables the immune system to attack tumours better. MPDL3280A has shown promising activity in lung cancer in earlier studies.
The drug will be administered intravenously (into the vein) on Day 1 of 21-day cycles. Treatment may be continued for a maximum of 16 cycles (or 12 months, whichever comes first). If patients complete this initial treatment stage, they will discontinue study drug, but will continue follow-up for up to 2 years. If a patient experiences worsening of his/her disease during the follow-up period, he/she may be allowed to restart MPDL3280A therapy. Patients entering the re-treatment stage may have their participation extended by up to 16 cycles or 12 months of study treatment. As such, the total duration of participation is dependent upon the follow-up period.
All patients will undergo a mandatory tumour biopsy sample collection, if clinically feasible, as well as tumour assessments (CT/MRI Scans) and other study procedures at visits outlined in the protocol.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/0983
Date of REC Opinion
18 Jul 2013
REC opinion
Favourable Opinion