Lung Cancer Clinical Studies NISCHR CRC

Lung Cancer Clinical Studies NISCHR CRC September 2010

Table of Contents 1 RECRUITMENT...3 1.1 SUMMARY OF RECRUITMENT IN WALES INTO UK APPROVED LUNG CANCER STUDIES...3 1.2 ALL WALES NCRN REPORTED LUNG CANCER STUDIES RECRUITMENT BY STUDY AND HOSPITAL (FINANCIAL YEAR 2009/10)...4 1.3 COMPARISON OF LUNG CANCER STUDIES RECRUITMENT WITH NETWORKS IN ENGLAND 2009/10...6 2 APPENDICES...7 2.1 APPENDIX 1: UK PORTFOLIO OF STUDIES (NCRN APPROVED)...7 Current Open UK Approved Studies by Disease Site (September 2010)..7 Current Open Approved Studies by Disease Site in Wales (September 2010)...7 2.2 APPENDIX 2: ALL WALES NCRN REPORTED LUNG RECRUITMENT BY STUDY AND MONTH (FINANCIAL YEAR 2009/10) BY REGIONAL NETWORK...8 2.3 APPENDIX 3: NCRN LUNG PORTFOLIO UK & WALES...9 2.4 APPENDIX 4: CONTACTS...12

1 Recruitment 1.1 Summary of Recruitment in Wales into UK Approved Lung Cancer Studies 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 N Wales 24 1 14 7 20 9 SE Wales 52 33 41 19 58 50 SW Wales 23 5 4 29 17 41 TOTAL 99 39 59 55 95 100 Recruitment in Wales into UK Approved Lung Cancer Studies Number Recruited 70 60 50 40 30 20 N Wales SE Wales SW Wales 10 0 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 Financial Year All data extracted from UKCRN Database during September 2010. During 2009-10 UKCRN have experienced difficulties with the completeness of Study activity reporting, this is likely to have resulted in under-reporting of WCRN Study activity data. Page 3 of 12

Randomised (RCT) vs. Non-randomised (Other) Lung Cancer Trials in Wales - Regional Breakdown (2006-10) Number Recruited 50 45 40 35 30 25 20 15 10 5 0 N Wales SE Wales SW Wales RCT Other RCT Other RCT Other RCT Other 2006/2007 2007/2008 2008/2009 2009/2010 Financial Year 1.2 All Wales NCRN Reported Lung Cancer Studies Recruitment by Study and Hospital (Financial Year 2009/10) North Wales BANG GCHR WREX Total BTOG2 (Nov-09)-C 0 2 0 2 FRAGMATIC (Jun-10) 0 1 2 3 MALCS (Mesothelioma and Lung Cancer Study) (Jul-10) 0 2 0 2 TACTIC (Jun-10) 0 1 1 2 Total 0 6 3 9 North Wales hospital codes: BANG Bangor Hospital GCHR Glan Clwyd Hospital, Rhyl WREX Wrexham Hospital Page 4 of 12

South East Wales POW CHW UHWC VEL LLAN NEVH PCMT RGH RGL Total BTOG2 (Nov-09)-C 0 0 0 1 2 0 0 0 0 3 FRAGMATIC (Jun-10) 1 0 0 2 11 4 2 14 0 34 LungStar (Jul-10) 0 0 0 2 0 0 0 2 0 4 MALCS (Mesothelioma and Lung Cancer Study) (Jul-10) 0 0 0 0 0 2 0 1 0 3 ReSoLuCENT (Jun-10) 0 0 0 4 0 0 0 0 0 4 TACTIC (Jun-10) 0 0 0 2 0 0 0 0 0 2 Total 1 0 0 11 13 6 2 17 0 50 South East hospital codes: POW Princess of Wales, Bridgend CHW Children s Hospital, Cardiff UHWC University Hospital of Wales, Cardiff VEL Velindre Hospital, Cardiff LLAN Llandough, Cardiff NEVH Nevill Hall, Abergavenny PCMT Prince Charles, Merthyr Tydfil RGH Royal Gwent, Newport RGL Royal Glamorgan, Pontypridd South West Wales PPHL WWGH BRON MOR SING WYBH Total ET Trial (Jul-10) 0 0 0 0 1 0 1 FRAGMATIC (Jun-10) 0 7 0 0 2 0 9 LungStar (Jul-10) 0 1 0 0 4 1 6 MALCS (Mesothelioma and Lung Cancer Study) (Jul-10) 0 0 1 0 24 0 25 Total 0 8 1 0 31 1 41 South West hospital codes: PPHL Prince Phillip, Llanelli WWGH West Wales, Carmarthen BRON Bronglais, Aberystwyth MOR Morriston, Swansea SING Singleton, Swansea WYBH Withybush, Haverfordwest NPT Neath / Port Talbot NB. Bracketed dates indicate month of last recruitment upload to UKCRN for that particular study. Page 5 of 12

1.3 Comparison of Lung Cancer Studies Recruitment with Networks in England 2009/10 Region Page 6 of 12 Network Population (m) Patients Recruited to Lung Studies England Arden NCRN 1 56 Avon, Somerset & Wiltshire NCRN 1.66 118 Black Country NCRN 1 0 Central South Coast NCRN 2.3 75 Derby/Burton NCRN 0.8 33 Dorset NCRN 0.7 30 Essex NCRN* 1.3 38 Greater Manchester & Cheshire NCRN 3 198 Greater Midlands NCRN* 2.06 101 Humber and Yorkshire Coast NCRN 1 49 Kent & Medway NCRN 1.6 59 Lancashire and South Cumbria NCRN 1.45 108 Leics, Northants & Rutland NCRN 1.4 118 Merseyside & Cheshire NCRN 2.14 233 Mid Anglia NCRN 1 4 Mid Trent NCRN 1.7 39 Mount Vernon NCRN 1.625 32 Norfolk and Waveney NCRN 0.7 37 North East London NCRN 1.5 20 North London NCRN 1.625 131 North of England North NCRN 2 39 North of England - South NCRN 1 24 North Trent NCRN 1.8 205 North West Midlands NCRN 1.2 0 Pan Birmingham NCRN 1.94 170 Peninsula NCRN 1.5 69 South East London NCRN 1.5 92 South Essex NCRN 0.7 0 South West London NCRN 1.75 90 Surrey, W Sussex & Hampshire NCRN 1.1 14 Sussex NCRN 1 15 Thames Valley NCRN 2.5 95 Three Counties NCRN 1.1 22 Unknown NCRN -- 38 West Anglia NCRN 1.375 194 West London NCRN 1.9 224 Yorkshire NCRN 2.5 162 England Total 51.065 2932 Wales Wales - North 0.7 9 Wales - South East 1.5 50 Wales - South West 0.8 41 Wales Total 3 100 * = Greater Midlands and Essex populations excluded from England population total for duplication reasons as these have been recently formed and are made up of other NCRNs listed in the table.

2 Appendices 2.1 Appendix 1: UK Portfolio of Studies (NCRN Approved) Current Open UK Approved Studies by Disease Site (September 2010) Cancer Site Number of Studies Percentage Brain 8 2% Breast 74 19% CCLG 32 8% Colorectal 29 7% Gynaecological 23 6% Haematological 34 9% Head & Neck 18 5% Lung 32 8% Lymphoma 23 6% Palliative Care 18 5% Sarcoma 10 3% Skin 9 2% Upper GI 36 9% Urology 43 11% Current Open Approved Studies by Disease Site in Wales (September 2010) Cancer Site Number of Studies Percentage Brain 2 1% Breast 30 22% CCLG 9 7% Colorectal 11 8% Gynaecological 5 4% Haematological 13 9% Head & Neck 6 4% Lung 12 9% Lymphoma 13 9% Palliative Care 2 1% Sarcoma 1 <1% Skin 3 2% Upper GI 17 12% Urology 14 10% Page 7 of 12

2.2 Appendix 2: All Wales NCRN Reported Lung Recruitment by Study and Month (Financial Year 2009/10) by Regional Network 2009 2010 North Wales Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Total BTOG2 (Nov-09) 0 0 0 1 1 0 0 0 0 0 0 0 2 FRAGMATIC (Jun-10) 2 0 0 0 0 0 0 0 0 1 0 0 3 LungStar 0 0 0 0 0 0 0 0 0 0 0 0 0 MALCS (Mesothelioma and Lung Cancer Study) (Jul-10) NCRN017 - INDUSTRY STUDY 0 1 0 0 0 0 0 1 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 SOCCAR 0 0 0 0 0 0 0 0 0 0 0 0 0 TACTIC (Jun-10) 1 0 0 0 0 1 0 0 0 0 0 0 2 TOPICAL 0 0 0 0 0 0 0 0 0 0 0 0 0 Total 3 1 0 1 1 1 0 1 0 1 0 0 9 South East Wales Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Total BTOG2 (Nov-09) 2 0 0 0 0 1 0 0 0 0 0 0 3 ET Trial 0 0 0 0 0 0 0 0 0 0 0 0 0 FRAGMATIC (Jun-10) 3 3 3 3 0 2 1 3 1 4 5 6 34 LungStar (Jul-10) 0 0 0 0 0 0 0 0 1 1 2 0 4 MALCS (Mesothelioma and Lung Cancer Study) (Jul-10) 0 0 1 0 1 0 1 0 0 0 0 0 3 ReSoLuCENT (Jun-10) 0 0 0 0 0 0 0 0 1 0 2 1 4 TACTIC (Jun-10) 0 0 0 1 0 0 0 1 0 0 0 0 2 TIME1 0 0 0 0 0 0 0 0 0 0 0 0 0 TIPS 0 0 0 0 0 0 0 0 0 0 0 0 0 TOPICAL 0 0 0 0 0 0 0 0 0 0 0 0 0 Total 5 3 4 4 1 3 2 4 3 5 9 7 50 South West Wales Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Total ET Trial (Jul-10) 0 0 0 0 0 0 0 0 0 0 0 1 1 FRAGMATIC (Jun-10) 0 0 3 0 0 0 0 1 2 3 0 0 9 LungStar (Jul-10) 2 0 0 1 0 0 0 1 0 2 0 0 6 Page 8 of 12

MALCS (Mesothelioma and Lung Cancer Study) (Jul-10) 3 4 1 1 2 0 0 2 2 7 1 2 25 TOPICAL 0 0 0 0 0 0 0 0 0 0 0 0 0 Total 5 4 4 2 2 0 0 4 4 12 1 3 41 GRAND TOTAL 15 11 12 8 5 3 2 12 11 29 11 13 132 NB. Dates in brackets show last month of recruitment upload to UKCRN database for that particular study. 2.3 Appendix 3: NCRN Lung Portfolio UK & Wales Open Studies Acronym Description Open in Wales Patient/s recruited to date in Wales ASyMS-R Improving the symptom experience of patients with lung cancer receiving radiotherapy: Advance Symptom Management System for Radiotherapy CLUB Cancer of the Lung Biomarkers "The CLUB Trial" CONVERT A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status ET Trial A multicentre, randomised, phase III trial of platinum-based chemotherapy versus non-platinum chemotherapy, after ERCC1 stratification, in patients with advanced/metastatic non-small cell lung cancer Experiences of episodic breathlessness Experiences of episodic breathlessness in patients with advanced disease FLT PET to assess tumour proliferation during radical radiotherapy CT-18FLT- PET sequential imaging protocol to assess tumor proliferation during radical radiotherapy FRAGMATIC A randomised phase III clinical trial investigating the effect of FRAGMin Added to standard Therapy In patients with lung Cancer Living Well with Lung Cancer Living well with lung cancer: evaluating the effectiveness of a sustainable model of follow-up care LLP Liverpool Lung Project Lung-BOOST A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and Staging: A Randomised Controlled Trial (Lung-BOOST) Lung-SEARCH A randomised controlled trial of surveillance for the early detection of lung cancer in a high-risk group. LungStar A multicentre phase III randomised double blind placebo contolled trial of pravastatin added to firstline standard chemotherapy in patients with small cell lung cancer Page 9 of 12

MALCS (Mesothelioma and Lung Cancer Study) A population based case-control study of mesothelioma and lung cancer in relation to occupation among British men and women MEDLUNG Early detection of lung cancer: metabolic biomarkers for high risk screening MESOVATS Prospective randomised controlled trial of videoassisted thoracoscopic (VATS) cytoreductive pleurectomy compared to talc pleurodesis in patients with suspected or proven malignant mesothelioma. Modafinil for Fatigue in Lung Cancer Modafinil for the treatment of fatigue in lung cancer: a multicentre, randomised, double-blinded, placebo controlled trial NCRN019 - INDUSTRY STUDY A Double-Blind, Randomised, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Recmage-A3 + As15 Antigen Specific Cancer Immunotherapeutic As Adjuvant Therapy In Patients With Resectable Mage-A3-Positive Non- Small Cell Lung Cancer NCRN032 - INDUSTRY STUDY Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non- Small Cell Lung Cancer Other than Predominantly Squamous Cell Histology NCRN073 A Phase III, multi-center, placeboâ controlled trial of Sorafenib (BAY 43-9006) in patients with relapsed or refractory advanced predominantly non squamous Non-Small Cell Lung Cancer (NSCLC) after 2 or 3 previous treatment regimens NCRN095 (FORTIS-M) FORTIS-M: A Phase 3, randomised, double-blind, placebo-controlled study of oral talactoferrin in addition to best supportive care in patients with non-small cell lung cancer who have failed two or more prior treatment regimens NCRN144 - TCD11420 A randomised phase 2 trial of Gemcitabine/Cisplatin with or without SAR240550 (a PARP1 inhibitor) in patients previously untreated for advanced non-small cell lung cancer NMES trial Is neuromuscular electrical stimulation an acceptable and feasible supportive therapy for patients with non-small cell lung cancer receiving palliative chemotherapy? Primary Care and Lung Cancer Follow Up QUARTZ ReSoLuCENT RESTORE-AIR What is the optimal role for primary care in the management and follow-up of patients with lung cancer? A phase III multicentre randomised controlled trial to assess whether optimal supportive care (including dexamethasone) alone is as effective as optimal supportive care (including dexamethasone) and whole brain radiotherapy (WBRT) in the treatment of patients with inoperable brain metastases from non-small cell lung cancer (NSCLC). Resource for the Study of Lung Cancer Epidemiology in North Trent Randomised Evaluation of STents to Open REstricted AIRways in patients with centrally placed non-small cell lung cancer Page 10 of 12

TACTIC A randomised phase II double blind placebo controlled trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer (NSCLC) with brain metastases TIPS The Inhaled Particles Study Tumour Angiogenesis Tumour Angiogenesis in Non-small cell Lung, Colorectal and Breast Cancer: Radiology- Pathology and Prognostic Correlation Studies in Set-up Acronym Description CHART-ED Continuous Hyperfractionated Accelerated Radiotherapy - Escalated Dose Study IDEAL-CRT Lung ART Qualitative interviews with lung cancer patients Supportive Care Intervention for Lung Cancer Patients and Caregivers UKLS Isotoxic Dose Escalation and Acceleration in Lung Cancer ChemoRadiotherapy - A phase I/II trial of concurrent chemoradiation with dose-escalted radiotherapy in patients with stage II or stage III Non-Small Cell Lung Cancer Phase III study comparing post-operative conformal radiotherapy to no postoperative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 Involvement (EORTC 22055-08053) Interviewing surgically treated lung cancer patients about their physical and psychological health, and their views about ways the national health service can help them rehabilitate. A non-pharmacological supportive care intervention for patients with lung cancer and their caregivers in the management of the respiratory distress symptom cluster UK Lung Cancer Screening Trial (UKLS) - Feasibility study and protocol development Page 11 of 12

2.4 Appendix 4: Contacts Research Network Managers and Clinical Leads Position Contact Name E-Mail Telephone North Wales Network Manager North Wales Clinical Lead Jackie Morris Jackie.Morris2@wales.nhs.uk 01745 448681 Dr Simon Gollins Simon.Gollins@wales.nhs.uk 01745 445161 South West Wales Network Manager Jayne Caparros Jayne.Caparros@ wales.nhs.uk 01792 285200 South West Wales Clinical Lead Dr Gian Filippo Bertelli Gianfilippo.Bertelli@ wales.nhs.uk 01792 205666 ext. 6412 South East Wales Network Manager Sara Shankland Sara.Shankland@ wales.nhs.uk 029 2019 6193 South East Wales Clinical Lead Dr John Staffurth John.Staffurth@wales.nhs.uk 029 2061 5888 ext. 6353 Clinical Research Centre contact details Position Contact Name E-Mail Telephone Director Professor John Wagstaff John.Wagstaff@wales.nhs.uk 01792 285299 Associate Director Libby Batt Libby.Batt@wales.nhs.uk 029 2019 6808 Training & Development Manager Information Systems Specialist PA to Associate Director Zoe Whale Zoe.Whale@wales.nhs.uk 029 2019 6816 Kumari Podila Kumari.Podila@wales.nhs.uk 029 2019 6803 Sue Edwards Sue.Edwards4@wales.nhs.uk 029 2019 6808 Please send feedback on this report to Kumari Podila, Information Systems Specialist (WCTN). Page 12 of 12