G027820 - MetMAb in 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 Paclitaxel and Cisplatin or Carboplatin as First-line Treatment for Patients with Stage IIIB (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
108240
Contact name
Joyce Thompson
Sponsor organisation
F.Hoffmann-La Roche
Eudract number
2011-003720-12
Clinicaltrials.gov Identifier
Research summary
Lung cancer is the most common cancer diagnosis and leading cause of cancer death worldwide. Non-small cell lung cancer (NSCLC) is one of two major types of lung cancer, accounting for approximately 85% of all lung cancer types. Squamous NSCLC accounts for approximately 25% 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 addition of taxanes (e.g paclitaxel) has been shown to prolong survival compared to single-agent treatment. The Met receptor is important in cancer growth, survival and spread. Onartuzumab (MetMAb) is a monoclonal antibody (a type of protein normally made by the immune system to help defend the body from infection) that attaches to the Met receptor and prevents Met from activating tumour cells. The purpose of this study is to assess the efficacy of MetMAb paclitaxel platinum compared to placebo (dummy drug) paclitaxel platinum. Patients with late stage squamous NSCLC who have received no prior chemotherapy may be eligible. They will be randomly assigned in a 1:1 ratio to either: - Arm A: paclitaxel, and either cisplatin or carboplatin, and MetMAb, or - Arm B: paclitaxel, and either cisplatin or carboplatin, and placebo Participants will receive a maximum of 4 cycles (each cycle is 21 days) of chemotherapy with MetMAb or placebo. Participants will then receive maintenance treatment with MetMAb or placebo until disease progression, unacceptable side effects or death. Participants will attend study visits at the beginning of each cycle. Procedures include physical examination, vital signs, ECG, blood and urine sampling, and CT or MRI scans. This study is sponsored by F. Hoffmann-La Roche Ltd. Approximately 110 participants will participate in this study worldwide with 15 participants from 4 hospitals in the UK.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
12/WM/0160
Date of REC Opinion
1 Aug 2012
REC opinion
Further Information Favourable Opinion