NCRI Lung Cancer Clinical Studies Group. Annual Report 2013/2014

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1 NCRI Lung Cancer Clinical Studies Group Annual Report 2013/2014

2 NCRI Clinical Studies Groups Reporting Metrics NCRI Lung Cancer Clinical Studies Group Data National comparison Section # Indicator Lowest Highest Disease 1 Incidence of disease (UK) ,232 48,988 2 Mortality of disease UK) ,042 Members 3 Number of Scientific Members on CSG Number of Subgroups Number of Taskgroups Number of Consumers involved in CSG, Subgroup and Taskgroup activities Portfolio 7 Total number of academic/industry sponsored portfolio studies opening in year Number of academic/industry sponsored portfolio studies open Total number of portfolio studies(academic and industry sponsored) closing in year Number of studies conducted internationally (outside UK) open Number of Industry Alliance Studies open in year Participation in International Rare Cancer Initiative (IRCI) Yes Portfolio Delivery 13 Total number of participants recruited (All CSG portfolio studies) Total number of cancer patients recruited (All CSG portfolio studies) Proportion of cancer patients recruited by disease Proportion of cancer patients recruited to interventional studies (where applicable - all CSG portfolio studies) Number of non cancer participants recruited to studies (All CSG portfolio studies) Total number of participants recruited to industry sponsored studies (All CSG portfolio studies) Proportion of CSG industry sponsored studies closing in year and delivered to time & target 4/12 33% 0/1 0% 6/6 100% 20 Proportion of other CSG academic studies closing in years and delivered to time & target 7/11 64% 0/2 0% 1/1 100% 21 Number of Local Research Networks active in delivering portfolio Output 22 Number of peer review publications directly associated with CSG portfolio studies Awareness raising/educational events No Progress Review 24 Date of last Progress Review Jan Date of next Progress Review Dec-14

3 NCRI Lung Cancer CSG Annual Report 2013/14 1. Executive Summary The Lung CSG remains active and with good enthusiasm from new members but there are several challenges to the Group. Increased pressures on NHS colleagues (clinical and from managers) do not allow time to be allocated to national work in many Trusts/Health Boards and this limits the time away from base that members can dedicate. It also probably explains the difficulty in getting members to commit to the NICE review processes that demand input several times a year. As with many groups, the same people volunteer each time. One member was asked to resign this year due to patchy attendance and failure to engage. The limitation in membership means that there has to be a robust approach to those who do not contribute to the group s work. Clinical trials are increasingly run for small groups of genetically selected lung cancer patients, and the relative rarity of these patients with mutations is a challenge to recruitment. Many centres do not routinely check for genes to be targeted by novel agents in commercial trials, and companies will not pay for them to be done. It is hoped that the Stratified Medicine Programme (SMP2) may help with this issue but clearly not all UK centres can be involved in that. In SCLC and mesothelioma there is more opportunity for broader entry criteria, but clearly these tumour types are less common than NSCLC. Fewer investigator-led initiatives are submitted, and we aim to be as supportive and positive as possible of those that are proposed. 2. Top three achievements in the year The top three achievements of the Lung CSG in the last year are: Maintenance of a large commercial portfolio; some excellent recruitment to difficult trials raises the UK profile (e.g. SELECT1 in KRAS positive second line NSCLC treatment) while challenges of the small numbers of patients eligible for mutation-directed studies are well recognised. Development of a modern, all encompassing set of trials to optimise radiotherapy for stage III NSCLC Mesothelioma portfolio is growing; translationally driven therapies are becoming more common to afford targeted therapies in this area. 3. Structure of the Group There remain four subgroups with (usually) virtual meetings of these for studies and strategy to be discussed between the twice yearly whole committee meetings. Pressure of time and international meeting commitments can limit availability of members for discussions, but subgroup reports summarising the work of the members are presented at CSG meetings. We have an enthusiastic new consumer member, and are delighted with the ready engagement of 1

4 our two members with all aspects of the CSG activities. It is likely that there will be changes in subgroup chairs in the coming year, and every effort is made to keep the subgroups fresh with new members. 4. Achievements, strategy, aims and challenges of the subgroups According to subgroup reports, there is regular discussion and good member engagement in clinical trials. LOcoRegionalDisease Subgroup (LORD) Subgroup National meetings organised by the LORD Subgroup were well attended, stimulated much debate and resulted in broad agreement in the excellent trial applications. Three phase I dose escalations studies completed recruitment (CHART-ED, IDEAL-CT and I-START) with the follow on phase II studies (ADSCaN and CITADEL) submitted for funding. The development of study ideas for stereo-tactic ablative radiotherapy has been an area of particular activity. Meetings contributed to the development of investigator lead initiatives for an adjuvant chemotherapy proposal (Professor M O Brien) and a study of follow up after lung cancer surgery (Mr E Lim), recently been supported by NIHR. Mesothelioma Subgroup The Mesothelioma Subgroup meets virtually and the number of trials is increasing, with the aim of having patients with all stages of disease eligible for a trial which will normally include a translational endpoint. The successful international presentations of the MesoVATS and ADAM trials have changed practice and resulted in a new target for therapy. Two meetings in May 2014 in London and Glasgow brought together international expertise in imaging as well as science, and the subgroup strategy is to increase collaboration to optimise novel diagnostic and therapeutic approaches as the incidence of Mesothelioma increases. Advanced Disease Subgroup The Advanced Disease Subgroup is busy with discussion of trials that target specific groups of lung cancer patients. There have been fewer investigator initiated studies, and the subgroup chair aims to try to encourage these while ensuring that all proposals are met with constructive criticism instead of comments that may deter potential CIs. The planned MATRIX trial that builds on tumour gene profiles in patients with advanced NSCLC is proving challenging to finalise but will be of key importance in delivery of a modern, pharma linked portfolio. Screening & Early Diagnosis Subgroup The Screening & Early Diagnosis Subgroup has a large remit and results from the main studies are soon to be available. This will raise the profile of this important aspect of lung cancer care. Having had relatively few studies in the portfolio over the last few years, 2013 has proved a good year with a number of new studies coming through. Studies around smoking cessation are lacking 5. Task groups/working parties We have had no specific working parties but did co-host with NIHR and DoH England a meeting dedicated to mesothelioma research on 2 nd May, To date no trial has been proposed as a result of the discussions, but links between clinicians and scientists were enhanced and successful outcomes regarding new proposals should be seen by early

5 6. Patient recruitment summary for last 5 years The number of patients with lung cancers and mesothelioma is no less over this 5-year period, but we have not been as successful as we would have liked in increasing trials inclusion, although numbers in non-interventional trials have increased. Some centres are at capacity for trials, and the challenge is to engage other centres with trials that can include all comers e.g. STOMP maintenance in SCLC. Table 1 Summary of patient recruitment by RCT/Non-RCT Year All subjects Cancer patients only % of cancer patients relative to incidence Non-RCT RCT Non-RCT RCT Non-RCT RCT 2009/ / / Table 2 Summary of patient recruitment by Interventional/Non-interventional Year All participants Cancer patients only % of cancer patients relative to incidence Noninterventional Interventional Noninterventional 3 Interventional Noninterventional 2012/ / Links to other CSGs and international groups There are close links between the Lung CSG and the EORTC with several members on both groups. Some studies especially radiotherapy based are run jointly and recruitment to these has been good e.g. crest in SCLC. ETOP is gaining in importance since more clinical trials are being developed by that group in which again several CSG members are involved e.g. PARAMOUNT in bone metastases. Professor Dean Fennel, who chairs the Mesothelioma Subgroup, is closely involved with the International Mesothelioma Group (IMIG). Dr Sanjay Popat, who chairs the Advance Disease Subgroup, is an active member of the International Rare Cancers Initiative (IRCI) with a special influence on thymoma where international clinical trials are being developed. 8. Funding applications in last year The CSG was pleased that Professor Ming Lee s proposal for a further SCLC trial was endorsed. He has an excellent track record in delivering original trials, relevant to modern clinical practice even when the results are negative. Professor Lee is one of the most active and prolific CSG members; his contributions are valued. Professor Dean Fennel s involvement with the EORTC complements his work as Mesothelioma Subgroup Chair through delivering a modern, busy, translationally based portfolio that will change systemic practice. The progress of the radiotherapy trialists in lung cancer continues with Dr Landau s SARON trial, and the work Interventional

6 through LORD is commended since confidence seems to have been reinstated in the funding bodies for RT based trials. DARWIN is the latest in the innovative, important studies fronted by Professor Charlie Swanton. We fully expect such trials as TRACERx, DARWIN and MATRIX to ensure a place on the podium at international meetings, and authorship in high impact journals for UK lead investigators. Funding submission during the reporting year can be seen below in Table 3. Table 3 Funding submissions in the reporting year Clinical Trials Advisory and Awards Committee (CTAAC) Study Application type CI Outcome July 2013 A phase II, multicentre, randomised trial comparing combination gemcitabine/carboplatin and hydroxychloroquine with gemcitabine/carboplatin therapy alone in extensive stage small cell lung cancer (SCLC) November 2013 EORTC 1303-LCG: A phase IIA trial to evaluate the efficacy of MCL-1 transcriptional suppression by epirubicin in patients with relapsed 1q21.2 amplified lung adenocarcinoma Prospective collection of tumour and blood samples from patients enrolled into the CRUK VIM, PIN and MESO2 IIB clinical trials March 2014 SARON: Stereotactic ablative radiotherapy for oligometastatic non-small cell lung cancer: a randomised phase III trial DARWIN 1: Deciphering afatinib response and resistance with intratumour heterogeneity 9. Industry sponsored trials portfolio Feasibility Application Feasibility Application *Endorsement* Sample collection application Outline application Feasibility application *Endorsement* Professor Ming Lee Professor Dean Fennell Professor Dean Fennell Siow Dr David Landau Dr Martin Forster & Professor Charles Swanton There are a number of commercial studies on the portfolio. Most weeks there are s requesting comment from several CSG members on the suitability for trials for UK practice. Almost all of the NSCLC trials are for small populations of patients who harbour specific (rare) mutations. In the first line setting it is difficult to identify these patients, but in second and third line settings the challenge is increased. Even with attempts to collaborate with other centres, it can prove impossible to recruit to these studies. The precarious state of the recruitment is communicated regularly by the NIHR CRN: Cancer central team via RAG reports. Clinicians remain keen to participate and are encouraged to be realistic about likely numbers of eligible patients so that UK accesses these interesting new drugs while minimising non-recruitment risk. New immune based studies where larger numbers of patients should carry a marker eg PD1, PDL-1, should result in a broader base of eligible patients. The STOMP study in SCLC is a welcome broad-based study of maintenance and recruitment should be good with this AZ sponsored trial. Many mesothelioma trials are still open to all patients, but better understanding of molecular biology may also limit recruits in the future. Endorsed *Deferred from March 2013 CTAAC meeting Not endorsed Revised submission requested Full application invited Endorsed 4

7 10. Collaborative partnership studies with industry The collaboration with AstraZeneca is the main link for the Lung CSG. STOMP (maintenance oliparib in SCLC) was born of this collaboration, and after many delays the trial is now recruiting well. There is a small group of medical oncologists who form the core group who participate in meetings with industry to advise and develop collaborative trials. There has been limited success and this continues to be a focus for the CSG. The important MATRIX trial, currently in development linked to the Stratified Medicine Programme SMP2, should increase the number of successful collaborations with other industry partners. 11. Progress towards achieving 3 year strategy International links are forging ahead (EORTC, ETOP, ITMIG, IMIG) and the CSG is also involved with the International lung cancer trials initiative started by Professor Paul Mitchell (Australia). This collaboration will ensure UK involvement in trials for rarer patient groups. We have a broad portfolio and continue to work towards increasing the number of patients recruited to clinical trials of all types. The improved radiotherapy portfolio will improve the chance of meeting a target of better recruitment. 12. Impact of clinical trials on routine UK clinical practice One of the most important and controversial trials completed and published by the Group is the MesoVATS which was presented by Dr Robert Rintoul at the World Lung Cancer meeting in Australia (November 2013). Patients with pleural mesothelioma who had video-assisted thoracoscopic partial pleurectomy compared to talc pleurodesis had better quality of live/symptom improvement but no longer survival. The MARS feasibility study of radical extraplerural pneumonectomy in mesothelioma produced passionate altercation since the investigators conclusion was that patients did not benefit from radical treatment. The debate continues, but the study remains important for having raised the quality of debate through generation of evidence by a randomised trial in a difficult area. In SCLC, prophylactic cranial irradiation is now offered to patients with extensive disease. We expect consolidation thoracic RT also to become the norm following positive results from the international CREST study in which UK was actively participating following heavy CSG support at the CTAAC funding process. The BTOG2 study excellent recruitment but annoyingly not yet in print after being well received following several international presentations has given oncologists confidence in prescribing whatever dose of carboplatin is calculated to be appropriate, even if it seems higher than normal. It also served to dissuade permanently the occasional practice of giving lower (<75mg/m2) doses of cisplatin since these are now known to provide inferior clinical benefit. Most other trials that have impacted practice are those on the commercial portfolio. Many centres participated in commercially sponsored post induction chemotherapy maintenance pemetrexed studies in NSCLC (e.g. PARAMOUNT), but the funding challenges have prevented implementation of maintenance pemetrexed in most parts of the UK, unlike the accepted best practice adopted in the rest of the world. 13. Consumer involvement Mr Mat Baker has provided full and active attendance at all CSG meetings and is actively involvement in LORD Subgroup. He provided peer review (e.g. MATRIX Trial), provided comment 5

8 on protocols and submissions for both main CSG and LORD Subgroup and is co investigator on two trial applications. As a member of NCRI SPADE and PPI Steering Group, under auspices of SPADE he was project lead for NCRI PPI Toolkit development and a member of the project team promoting analysis and dissemination of NCPES findings. Mr Baker was co-author of posters at NCRI Conference 2013 (NCPES findings) and NCIN Conference 2014 (NCPES findings) and author of paper at NIHR Involve Conference 2014 (NCRI PPI Toolkit applications). He is a member of the NCRI s working party reviewing consumer involvement across NCRI activities. Ms Myrna Gray, prior to her retirement after five years Lung CSG service, was involved in the PET steering group, stop smoking campaign, palliative care initiative and the showcase for writing and art. Mrs Janette Rawlinson attended induction training in October then her first CSG meeting in February To date, she has regularly commented on trial submissions to the CSG, and provided peer review of matrix trial/stratified medicine programme 2. Mrs Rawlinson participated on GRIPP 2 equator guidance advice research, is a member of NCRI SPADE (co-opted to write a report on surveys) and authored a report on surveys on consumer involvement in CSGs. She attended NCRI and NCIN conferences, BTOG in January and will attend the mesothelioma workshop in May. She met her scientific mentor at BTOG and again in February. Mrs Rawlinson commented on how she is impressed at how welcome she been made to feel and on meeting CSG members at events, how supportive they are. She was impressed at having a space to update CSG members at her first CSG meeting which provided an opportunity to update on changes in primary care from the commissioning work with which she is involved. 14. Open meetings /annual trials days There has been no annual trials meeting for several years, but it has been discussed on several occasions with the Head of the CSGs Secretariat that these should be reinstated to allow good exchange of data for ongoing and planned studies as well as raising enthusiasm for open studies on the portfolio, however the challenge is to raise sponsorship for this meeting. It is felt that BTOG - although the premier, excellent British forum for thoracic tumours can not replicate the outcomes of a dedicated annual trials showcasing meeting. It is hoped that funding can be raised for an annual trials day in Priorities and challenges for the forthcoming year Priorities are to: Improve patient recruitment to clinical trials of all types, whether commercial or not Ensure that the reorganisation of networks/nhs pressures in staffing and cost do not result in disengagement of potential and actual PIs in lung cancer and mesothelioma Integrate further the expertise of our consumer representatives to the core work of the CSG Challenges are to: Reach out to networks where lung cancer trial recruitment is lower than expected to offer help where reasons for non-engagement are identified Achieve required numbers in trials of rare patient groups (genetically defined) Continue to respond well and within deadlines to NICE and other organisations requests for CSG help 6

9 16. Concluding remarks The Lung CSG carries a large portfolio of trials and there is no dip in the number of commercial proposals coming through for members comments, although these are mainly in systemic therapies. There has been a great increase in funded radiotherapy trials and this is a recent triumph since the radiotherapy community are now keen to generate hard evidence for best practice. The background trials of screening are ongoing, and this will be an area of development in the next few years. Surgical trials in mesothelioma have been successful and in the near future there will be more window of opportunity and related studies in lung cancer surgery. I would like to see more nurse-led studies with symptom, quality of life and survival issues better addressed. The key roles of our enthusiastic consumer representatives will remain crucial to our success. 17. Appendices Appendix 1 Membership of main CSG and subgroups Appendix 2 Portfolio Maps Appendix 3 Publications in reporting year Appendix 4 Major international presentations in reporting year Dr Marianne Nicolson (Lung CSG Chair) 7

10 Appendix 1 Membership of the Lung CSG Name Mr Matthew Baker (CLG) Professor David Baldwin Professor Lucinda Billingham Dr Adam Dangoor Mr John Edwards Professor Dean Fennell Dr Susan Harden Dr Matthew Hatton Dr David Landau Professor Siow Ming Lee Mr John McPhelim Professor Gary Middleton Dr Neal Navani Dr Thomas Newsom-Davis Dr Marianne Nicolson (Chair) Dr Simon Noble Dr Noelle O'Rourke Dr Mick Peake Dr Sanjay Popat Dr Doris Rassl Ms Janette Rawlinson (CLG) Dr Robert Rintoul Dr Yvonne Summers Professor Edwin Van Beek Professor David Waller Location Manchester Nottingham Birmingham Bristol Sheffield Leicester Cambridge Sheffield London London East Kilbride Birmingham London London Aberdeen Newport Glasgow Leicester London Cambridge Wolverhampton Cambridge Manchester Edinburgh Leicester 8

11 Membership of the Subgroups Mesothelioma Subgroup Advanced Disease Subgroup Name Location Name Location Professor Dean Fennell (Chair) Leicester Dr Sanjay Popat (Chair) London Mr David Waller Leicester Dr Riyaz Shah Maidstone Dr Peter Jenkins Gloucestershire Professor Penella Woll Sheffield Dr Jeremy Steele London Professor Lucinda Billingham Birmingham Dr Michael Snee Leeds Dr Fiona Blackhall Manchester Professor Andrew Ritchie Essex Dr Michael Snee Leeds Professor Mike Lind Hull Dr Clive Mulatero Leeds Mr John Edwards Sheffield Dr Serban Ghiorghiu Scarborough Dr James Entwisle Leicester Dr Andy Hughes Newcastle Dr Hannah Lord Dundee LOcoRegionalDisease Subgroup (LORD) Dr Gary Middleton Birmingham Name Location Dr Jason Lester Cardiff Dr Matthew Hatton (Chair) Sheffield Dr James Spicer London Dr Corinne Faivre-Finn Manchester Dr Denis Talbot Oxford Screening/Early Diagnosis Subgroup Mr Babu Naidu Birmingham Name Location Dr David Landau London Dr Robert Rintoul (Chair) Cambridge Dr Richard Booton Manchester Dr Jesme Baird Liverpool Dr David Baldwin Nottingham Professor John Britton Nottingham Mrs Lavinia Magee Cambridge Professor Jessica Corner Southampton Mr Mat Baker Manchester Professor John Field Liverpool Dr Tom Newsom-Davis London Dr Jeremy George London Professor David Hansell London Dr Martin Muers Leeds Dr Clive Mulatero Leeds Mr David Ardron Barnsley Professor David Weller Edinburgh Dr Stewart Alasdair Gillingham 9

12 Appendix 2 Portfolio maps 10

13 11

14 12

15 13

16 Appendix 3 Publications in the reporting year UKLS McRonald FE, Yadegarfar G, Baldwin DR, Devaraj A, Brain KE, Eisen T, Holemans JA, Ledson M, Screaton N, Rintoul RC, Hands CJ, Lifford K, Whynes D, Kerr KM, Page R, Parmar M, Wald N, Weller D, Williamson PR, Myles J, Hansell DM, Duffy SW, Field JK. The UK Lung Screen (UKLS): demographic profile of first 88,897 approaches provides recommendations for population screening. Cancer Prev Res (Phila) Mar;7(3): doi: / CAPR Epub 2014 Jan 17. PMID: [PubMed - in process] TACTIC Lee SM, Lewanski CR, Counsell N, Ottensmeier C, Bates A, Patel N, Wadsworth C, Ngai Y, Hackshaw A, Faivre-Finn C. Randomised phase II placebo-controlled trial of whole brain radiotherapy and erlotinib in patients with advanced non-small cell lung cancer with multiple brain metastases Journal of the National Cancer Institute, in press CaDiAS Cancer diagnosis in the acute setting (CaDiAS): A study on behalf of the London Cancer Alliance.). Hughes C, Sarafraz-Shekary N, Kausha A, Ramirez A, Benepal T, Watts C, Forbes L & Newsom- Davis T. J Thor Oncol (2013); 8(2): S ASTER trial Rintoul RC, Glover MJ, Jackson C, Hughes V, Tournoy KG, Dooms C, Annema JT, Sharples LD.Cost effectiveness of endosonography versus surgical staging in potentially resectable lung cancer: a health economics analysis of the ASTER trial from a European perspective. Thorax Sep 24. doi: /thoraxjnl [Epub ahead of print] MesoVATS Rintoul RC, Ritchie AJ, Edwards JG, Waller DA, Coonar AS, Bennett M, Lovato E, Hughes V, Fox- Rushby JA, Sharples LD. Randomised controlled trial of video-assisted thoracoscopic partial pleurectomy compared to talc pleurodesis in patients with suspected or confirmed malignant pleural mesothelioma: the MesoVATs trial. Lancet CHART-ED Hatton M, Hill R, Wilson P, Atherton P, Morgan S, Dickson J, Murray K, Paul J. Continuous Hyperfractionated Accelerated RadioTherapy Escalated Dose: A Phase I study. Radiotherapy and Oncology 111suppl 1 S231;

17 Appendix 4 Major international presentations in the reporting year MesoVATs trial Randomised controlled trial of video-assisted thoracoscopic partial pleurectomy compared to talc pleurodesis in patients with suspected or confirmed malignant pleural mesothelioma: the MesoVATs trial. World Conference on Lung Cancer Sydney October 2013 CaDiAS Cancer diagnosis in the acute setting (CaDiAS): A study on behalf of the London Cancer Alliance. Hughes C, Sarafraz-Shekary N, Kausha A, Ramirez A, Watts C, Forbes L & Newsom-Davis T. 9 th NCRI Annual Conference, Liverpool, November CHART-ED Hatton M, Hill R, Wilson P, Atherton P, Morgan S, Dickson J, Murray K, Paul J. Continuous Hyperfractionated Accelerated RadioTherapy Escalated Dose: A Phase I study., ESTRO Conference, Vienna, 2014 REST Slotman BJ, Faivre-Finn C, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Senan S. Randomized trial on chest irradiation in extensive disease small cell lung cancer (ES-SCLC). 50 th American Society of Clinical Oncology Meeting, Chicago,

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