HuMAb NO21160 advanced non-small cell lung cancer
Research type
Research Study
Full title
A Randomised, double blind study to determine the effect of two dose schedules of R1507 or placebo, both in combination with erlotinib (Tarceva®), on progression-free survival in patients with advanced non-small cell lung cancer with disease progression after first or second line chemotherapy
IRAS ID
10768
Sponsor organisation
F.Hoffmann-La Roche Ltd.
Eudract number
2008−001736−12
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
The drug R1507 is being studied by F.Hoffmann-La Roche Ltd. for advanced non-small cell lung cancer that has grown back or worsened after prior treatment with either 1 or 2 standard types of chemotherapy.The purpose of this study is to answer:1/ Does the combination of both R1507 and erlotinib, result in a better outcome compared to erlotinib administered with the placebo? 2/ Is the weekly administration of R1507 more or less effective or the same as the three weekly administration of R1507?3/ Does the combination of both R1507 and erlotinib, have less or more side effects compared to erlotinib administered with the placebo?R1507 is a type of protein designed to attack a part of the cell surface called the Insulin-Like Growth Factor Receptor (IGF1R). By blocking this surface component, it is hoped that R1507 will interfere with growth or spread of cancer cells or possibly kill the cancer cells. Erlotinib is an approved drug for patients with advanced non-small cell lung cancer after failing at least one prior chemotherapy regimen, and has shown benefits for patients in clinical trials. There will be approximately 150 participants enrolled in the study (43 per each arm) over a planned period of 24 months. It is expected that there will be approximately 40 participants in the UK.All participants will receive Erlotinib treatment and will be randomly assigned to either weekly or three weekly administration of R1507 or placebo. Participants will know whether they will receive weekly or three weekly treatments but will not know whether they are receiving R1507 (2 of every 3 patients) or placebo treatment (1 of every 3 patients). Thus, of 150 participants, 50 will receive Erlotinib R1507 given three weekly, 50 will receive Erlotinib R1507 given weekly, 25 will receive Erlotinib intravenous placebo given three weekly and 25 will receive Erlotinib intravenous placebo given weekly.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
08/H1107/195
Date of REC Opinion
23 Dec 2008
REC opinion
Further Information Favourable Opinion