WP29158-MPDL3280A & Erlotinib in advanced Non-Small Cell Lung Cancer
Research type
Research Study
Full title
A PHASE Ib STUDY OF THE SAFETY AND PHARMACOLOGY OF MPDL3280A ADMINISTERED WITH ERLOTINIB IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER
IRAS ID
156353
Contact name
Louisa Vass
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2013-004382-13
Duration of Study in the UK
1 years, 10 months, 24 days
Research summary
The purpose of this study is to determine a safe and tolerated dose of the combination of an experimental drug called MPDL3280A and an approvd therapy for Non-Small Cell Lung Cancer (NSCLC) called erlotinib. Although MPDL3280A and erlotinib given alone and in combination with other anticancer drugs have been tested in people with advanced cancer, the specific combination of MPDL3280A with erlotinib has not been used in people before.
There are two stages of this study:
Stage 1 (the safety evaluation stage) is for patients with advanced NSCLC who have never been treated with a type of therapy called an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).Stage 2 (the expansion stage) is for patients with advanced NSCLC which has previously been untreated (or with one prior treatment that was not an EGFR TKI therapy) but who also have a type of genetic mutation making them EGFR mutation positive.
The total planned number of patients for the entire study is 26-32:
Stage 1 will enroll 6-12 patients; and
Stage 2 will enroll 20 patients.Study duration will be up to 17 cycles (or 12 months, whichever comes first). Survival follow-up will be until death, loss to follow-up or study termination.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/2036
Date of REC Opinion
21 Jan 2015
REC opinion
Further Information Favourable Opinion