Spots Global Cancer Trial Database for National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer
Official Title: National Lung Matrix Trial: Multi-drug, Genetic Marker-directed, Non-comparative, Multi-centre, Multi-arm Phase II Trial in Non-small Cell Lung Cancer
Study ID: NCT02664935
Study Description
Brief Summary: The trial consists of a series of parallel multi-centre single arm phase II trial arms, each testing an experimental targeted drug in a population stratified by multiple pre-specified actionable target putative biomarkers. The primary objective is to evaluate whether there is a signal of activity in each drug-(putative)biomarker cohort separately. A Bayesian adaptive design is adopted to achieve this objective and statistical details are given in the Protocol.
Detailed Description: The trial is primarily an enrichment putative biomarker design, including patients who are positive for at least one of the actionable targets included in the trial. Patients who are positive for just one putative biomarker will receive the experimental targeted drug specific for that putative biomarker. Putative biomarkers within each drug cohort have been chosen such that in the majority of cases it is not expected that patients will be positive for two or more putative biomarkers within the same drug. In the rare situation that patients are positive for two or more putative biomarkers relevant across different drugs, treatment will be allocated in accordance with the following strategy: * All amplifications and rearrangements will be treated with targeted agent appropriate to them irrespective of concomitant mutations. This will yield crucial predictive biomarker information. * For concomitant mutations decisions will be made by the Chief Investigator on a case-by-case basis and based on close consideration of pathway preference and likely dominance of one signal pathway over another together with any pre-clinical efficacy studies that address the activity of the drugs in the presence of concomitant mutations. A trumping strategy has been devised for this purpose.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
Belfast City Hospital, Belfast Health and Social Care Trust, Belfast, , United Kingdom
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust, Birmingham, , United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
Velindre Cancer Centre, Velindre NHS Trust, Cardiff, , United Kingdom
Colchester General Hospital, Colchester, , United Kingdom
Edinburgh Cancer Centre, Western General Hospital, Edinburgh, , United Kingdom
Royal Devon and Exeter Hospital, Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
St. James' University Hospital, Leeds Teaching Hospital NHS Trust, Leeds, , United Kingdom
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust, Leicester, , United Kingdom
Royal Marsden Hospital, The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, , United Kingdom
Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust, London, , United Kingdom
University College Hospital, University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Maidstone Hospital, Maidstone, , United Kingdom
The Christie Hospital, The Christie NHS Foundation Trust, Manchester, , United Kingdom
Sir Bobby Robson Cancer Trial Research Centre, The Newcastle upon Tyne Hospitals, Newcastle, , United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Weston Park Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
Clatterbridge Cancer Centre, Wirral, , United Kingdom
Contact Details
Name: Gary W Middleton
Affiliation: University of Birmingham
Role: PRINCIPAL_INVESTIGATOR
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