Phase 3 Study evaluating MetMAB with TARVEVA in patients with NSCLC
Research type
Research Study
Full title
A Randomised, Phase III, Multicentre, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of MetMAb in Combination with Tarceva® (Erlotinib) in Patients with Met Diagnostic-Positive Non-Small Cell Lung Cancer (NSCLC) who have received standard chemotherapy for advanced or metastatic disease.
IRAS ID
88963
Contact name
Fiona Blackhall
Sponsor organisation
Genentech, Inc
Eudract number
2011-002224-40
Clinicaltrials.gov Identifier
Research summary
Lung cancer is the most common cancer in men and women and is the worldwide leading cause of cancer death. There are 2 major types with approximately 85% being Non-small cell lung cancer (NSCLC). Standard treatments include taxanes, vinorelbine, camptothecin analogs, gemcitabine, pemetrexed and bevacizumab. Combinations are used with platinum based drugs to prolong survival. Epidermal growth factor receptor (EGFR) is a treatment target in NSCLC. Targeted agents like erlotinib and gefitinib specifically inhibit the EGFR receptor and slow cancer cell growth. Erlotinib can prolong survival in NSCLC patients. However resistance eventually occurs. Molecular mechanisms such as genetic amplification and over-expression of Met drive the resistance to EGFR inhibitors. Data suggests that Met and EGFR cooperate to drive tumour growth and survival and therefore supports a strong rationale for combining Met and EGFR inhibitors in the clinic. MetMAb inhibits MET. A Phase I study of MetMAb in solid tumours showed MetMAb to be tolerable. A Phase II study of erlotinib MetMAb in patients with NSCLC, showed that patients with Met positive tumours had an improved Progression Free Survival. The safety profile for erlotinib MetMAb was similar to erlotinib alone. This suggests that MetMAb should be further evaluated as a second or third line treatment in Met diagnostic-positive NSCLC. Approximately 480 patients will take part with about 50 being from the UK. Patients will be in the study until their disease worsens, their doctor determines that their safety is at risk, the study treatment becomes intolerable, the patient chooses to stop study treatment, or the study is ended by the sponsor. Study procedures include physical examination, height, weight, vital signs, ECG, CT/MRI scans, blood and urine tests, pregnancy tests, drug administration, questionnaires. A biopsy might be required if sufficient tumour tissue is not available. This is a double-blind study sponsored by Genentech, Inc. All patients will receive erlotinib and MetMAb or Placebo.
REC name
North West - Haydock Research Ethics Committee
REC reference
12/NW/0241
Date of REC Opinion
18 Jun 2012
REC opinion
Further Information Favourable Opinion