MAPPING
Research type
Research Study
Full title
Double Blind randomized phase III study of maintenance Pazopanib versus placebo in NSCLC patients non progressive after first line chemotherapy. MAPPING, an EORTC Lung group study.
IRAS ID
69406
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2010-018566-23
Clinicaltrials.gov Identifier
Research summary
This study is a randomised phase III study aimed at patients with non-small cell lung cancer (NSCLC) who have completed a course of first line palliative (non curative) chemotherapy. This trial will assess if the drug pazopanib can 'maintain' and prolong the benefit or response after 4 courses of initial chemotherapy. Maintenance treatment after initial chemotherapy is showing promising results in the treatment of certain subgroups of NSCLC. However not everyone benefits and better treatments are needed that are suitable for all subgroups. Patients with be randomised to oral pazopanib or oral placebo. Disease activity will be monitored closely by CT scan so that if there is evidence of progression then patients can be offered secondline treatment at an early point.Pazopanib is an oral drug that has a number of sites of action on enzymes that are involved in blood vessels and cancer cell growth. Pazopanib can block these enzymes (tyrosine kinases) and thus shrink renal and lung cancers. The aim of the study is to compare the benefit of maintenance pazopanib versus placebo after first line treatment for NSCLC. The study will be analysed after 154 events (progression of disease or death) have occurred to make sure there are no concerns and that it is still worthwhile to recruit the total 587 patients. In addition, translational research in the laboratory will be performed on patients' blood and cancer tissue that have been collected, to measure the concentration of the drug in the blood and to look for markers from the targeted pathway which can be used in the future to predict how useful this treatment could be (pharmacogenetics and VEGFR pathway biomarkers). Information on quality of life in patients and use of health facilities (health economics) data will also be collected and analysed.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
11/LO/1066
Date of REC Opinion
23 Sep 2011
REC opinion
Further Information Favourable Opinion