GO27821 - MetMAb in non-squamous non-small cell lung cancer
Research type
Research Study
Full title
A Randomised, Phase II, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of MetMAb in Combination with either Bevacizumab + Platinum+ Paclitaxel or Pemetrexed + Platinum as First-Line Treatment in Patients with Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
108241
Contact name
Joyce Thompson
Sponsor organisation
F.Hoffmann-La Roche
Eudract number
2011-003719-42
Clinicaltrials.gov Identifier
Research summary
Lung cancer is the most common cancer diagnosis and leading cause of cancer death worldwide. NSCLC is one of two major types of lung cancer, accounting for approximately 85% of all lung cancer types. Non-squamous NSCLC accounts for approximately 70% of NSCLC cases. Standard of care for patients with advanced disease is platinum-based chemotherapy (e.g. cisplatin, carboplatin) for 4-6 cycles followed by maintenance treatment until disease progression. The Met receptor is important in cancer growth and spread. Onartuzumab (MetMAb) is a monoclonal antibody (type of protein normally made by the immune system to defend the body from infection) that attaches to the Met receptor and prevents Met activating tumour cells. The study purpose is to assess efficacy and safety of MetMAb with Bevacizumab, Paclitaxel and Platinum (Cisplatin or Carboplatin) or MetMAb with Pemetrexed and Platinum. Patients with late stage non-squamous NSCLC who have received no more than one period of chemotherapy may be eligible. Participants will be randomly assigned to one of two treatment arms in one of the following groups (the study doctor will determine which group each participant will be placed): GROUP 1 Arm A: MetMAb, Bevacizumab, Platinum and Paclitaxel Arm B: Placebo, Bevacizumab, Platinum and Paclitaxel GROUP 2 Arm A: MetMAb, Platinum and Pemetrexed Arm B: Placebo, Platinum and Pemetrexed Participants will receive 4 cycles of chemotherapy with MetMAb or placebo. After 4 cycles; Platinum (and Paclitaxel, if applicable) will be stopped and if the participant's tumour has decreased or remained stable they will be able to continue to receive either: Group 1: MetMAb or placebo with Bevacizumab Group 2: MetMAb or placebo with Pemetrexed. Patients will attend visits at the beginning of each cycle. Procedures include physical exam, vital signs, ECG, blood and urine sampling, CT/MRI scans. This study is sponsored by F. Hoffmann-La Roche Ltd.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
12/WM/0159
Date of REC Opinion
1 Aug 2012
REC opinion
Further Information Favourable Opinion