ALTG Clinical Trials Newsletter

Transcription

1 ALTG Clinical Trials Newsletter February 2012 President s Message Special points of interest: ACORD Workshop applications 27th February 2012 ALTG Group meeting in Sydney on March 23 Visit the ALTG website: Inside this issue: General Business 2 NITRO Trial 3 BR29 Trial 3 PACT in NSCLC Study 4 PA in Lung Study 4 Unmet needs in Lung Cancer B2P2M2 5 BR26 Trial 5 CHISEL Trial 6 ANTS 2 Trial 6 SCLC Concept Update 6 ALTG 10/002 Update 6 4 Welcome to the 9th ALTG newsletter! It does not seem very far into 2012, but our first group meeting will soon be upon us. This will be in Sydney on March 23. As well as the group meeting there will be a special forum for consumers. ALTG strongly supports consumer involvement in cancer research and cancer control activities, and we are mindful that consumer involvement in lung cancer programs has been more difficult to achieve than in some other cancer types. ALTG is very fortunate to have the committed consumers we have. I attended the COSA council and the COSA Annual Meeting in Perth in November There is a general agreement from all the cancer clinical trial groups to work together as we all face the same or similar issues and COSA will be facilitating this. These include the need to secure long-term funding outside of Cancer Australia which currently only funds for 3 year cycles, Upcoming Meetings 2011 the need to develop common procedures for clinical trial audit, the need for coordinating consumer involvement and training, the need to improve access to clinical trials for regional/rural patients, and Prof Michael Millward ALTG President the need to ensure support for biobanking and other long-term projects. COSA 2011 did not have lung cancer as a theme but there was an excellent session on mesothelioma featuring Paul Bass (Netherlands). COSA will not focus on lung for a few years as this year we have the Australasian Lung Cancer Conference in Adelaide in August and of course 2013 is the World Lung cancer Conference in Sydney. Our clinical trials program continues and is summarised in this newsletter. We are continuing to develop new concepts in small cell lung cancer and mesothelioma. With the start of the New Year, we are currently finalising the appointment of new ALTG Clinical Research fellows, and this should be completed by the March 23 meeting. I hope to see as many ALTG members as possible in Sydney on March 23. ALTG 10/003 Update 7 ALTG 10/004 Update 7 ALTG 11/001 Update 7 The ALTG greatly acknowledges the support from: 23 February 2012 Closed SAC Teleconference 1.30pm 2.30pm AEDST 1 March 2012 Closed MAC Teleconference 1.30pm 2.30pm AEDST 23 March 2012 Closed combined MAC&SAC Face to Face Meeting Stamford Plaza Sydney Airport 9.30am am AEDST 23 March 2012 ALTG Group Meeting (with workshop) - Stamford Plaza Sydney Airport - All ALTG members welcome Group meeting 11.30am to 1.30pm. Workshop 2.00pm pm AEDST

2 Page 2 ALTG General Business ALTG Group Meeting Friday, 23rd March 2012 The next ALG Group meeting will be held at the Sydney Airport Stamford Plaza Hotel from 11.30am to 1.30pm (AEST) followed by an ALTG workshop. This meeting will be an opportunity to catch up with other ALTG members and hear updates on current ALTG trials and concepts in development. Travel scholarships are available for ALTG members wishing to attend. If you would like to take advantage of a travel scholarship please contact Nigel McPaul at nigel@lungfoundation.com.au to make your travel arrangements. ALTG Workshop Presentation and Discussion by the Consumer Health Forum (directly following the ALTG Group Meeting) Following the ALTG Group Meeting on Friday 23rd, March 2012 a workshop organised by the ALTG will be held from 2.00pm to 3.00pm (AEST). The workshop will be facilitated by the Consumer Health Forum and will consist of a presentation on the clinical trials consumer factsheet followed by a presentation and Q&A with a consumer who has taken part in clinical trials. This will be a great opportunity for anyone working in clinical trials today. NHMRC Concept Development Workshop for Trials and Translational Research Studies Friday 30th March 2012 ALTG members are invited to attend the NHMRC Concept Development Workshop for Trials and Translational Research Studies to be held from 9am to 5pm on Friday 30th March at The University of Sydney, NSW. The workshop is designed for investigators who have an idea for a clinical trial. Investigators from any therapeutic area or discipline are welcome to attend. Participants are required to submit a brief outline of their proposed study by Friday 23rd, March 2012 by using the concept template provided upon registration. Registration forms were ed to ALTG members but if you would like another copy sent to you please Nigel McPaul at nigel@lungfoundation.com.au Australian Lung Cancer Conference 2012 ALTG members are invited to attend the 4th Australian Lung Cancer Conference which will be held at the Adelaide Convention Centre in South Australia from Thursday 23rd August to Saturday 25th August The program will feature the second of the two ALTG Group meetings. The conference aims to provide a forum to raise and discuss issues relating to Translating Advances into Clinical Practice in a multidisciplinary team environment. Plenary sessions will be relevant, interactive and focused on producing an outcome relative to multidisciplinary care. Confirmed keynote speakers include doctors: Peter Goldstraw (UK), Pasi A. Jänne (USA) and Frederico Cappuzzo (Italy) and Mark Kris (USA). For more information visit the conference website at Membership The ALTG membership currently stands at 317 which has been a great effort. Prospective members can now apply online to become an ALTG member at Please encourage your colleagues, especially those in rural/ regional areas, to become members. State NSW VIC QLD SA WA ACT TAS NT # Members NZ/OS 18 Contact: Nigel McPaul ALTG Liaison Officer Phone: nigel@lungfoundation.com.au 2012 ACORD Workshop Applications close on 27th February Funding is available from ALTG to sponsor a trainee or recently appointed consultant ALTG member to attend the ACORD Protocol Development Workshop from Sunday 9th September to Saturday 15th September 2012 on Queensland s Sunshine Coast. The Workshop is designed as a week-long intensive training program focused on the essentials of clinical trials design for cancer researchers in oncology subspecialties from Australia and the Asia Pacific region. ACORD s aims include: Imparting principles of good clinical trial design, which yield clear results to apply in the clinic and in future research Exposing participants to the full spectrum of challenges in clinical research from conventional antineoplastic agents and multidisciplinary treatment regimens to biological therapy Cultivating well-trained, experienced researchers to propel the region forward in cancer therapy and prevention through clinical trials, medical practice and patient care Fostering collaboration and facilitation of clinical trials in the region Applications for the workshop opened in November 2011 and close on 27th February Applicants are required to submit an application including a one-page outline of a concept to bring to the workshop. For further information visit the ACORD Workshops website at and select Registration on the left-hand side of the web page.

3 Page 3 ALTG 06/003 - NITRO Trial A phase III, multi-centre randomised trial of adding nitroglycerin to first line chemotherapy for advanced non small cell lung cancer. The recruitment target is 500 participants. The Nitro trial has been open since May 2009 and there are 22 sites activated, with 161 patients enrolled. Nitro Recruitment The Prince Charles Hospital (25) Royal Perth Hospital (18) Coffs Harbour Hospital (26) Tamworth Hospital (1) Armidale Hospital (0) The Alfred (4) Port Macquarie Hospital (18) Prince of Wales Hospital (9) Nepean Hospital (6) Royal Hobart Hospital (3) Nambour Hospital (10) Bendigo Hospital (5) Royal Prince Alfred Hospital (14) Sir Charles Gairdner Hospital (8) Liverpool Hospital (0) Townsville Hospital (6) Bankstown-Lidcombe Hospital (1) Cairns Base Hospital (1) Tweed Hospital (6) Holy Spirit Northside (0) Newcastle Private Hospital (0) Concord Hospital (0) ALTG 09/001 - BR29 Trial BR29 is a double blinded, randomised controlled trial of cediranib versus placebo in patients receiving standard paclitaxel/ carboplatin chemotherapy for the treatment of advanced or metastatic non small cell lung cancer. This multicentre, international phase III trial is being coordinated by the NCIC Clinical Trials Group in collaboration with the NHMRC Clinical Trials Centre and Australasian Lung cancer Trials Group. The first BR29 site was opened in June 09, with the remaining 11 stage I sites opening the following year. These centres managed to recruit 88 patients for stage I of the study: Royal Prince Alfred Hospital, NSW (24) Southern Medical Day Care Centre, NSW (19) Peter McCallum Cancer Centre, VIC (9) Sir Charles Gairdner Hospital, WA (8) Liverpool Hospital, NSW (5) Nambour Hospital, QLD (7) Geelong Hospital, VIC (2) St Vincent s Hospital, VIC (1) Flinders Medical Centre, SA (5) Royal Melbourne Hospital, VIC (4) Western Hospital, VIC (2) Royal Adelaide Hospital, SA (1) The first interim safety analysis was undertaken without any issues. A cancer Australia project grant was awarded in 2011 to fund this trial for 3 years, as a result additional sites have been invited to participate on this trial. This has resulted in another 7 sites expressing interest, all these sites are expected to be active by the end of this year. We plan to seek ALTG approval and then to apply for funding to add FDG PET scanning across sites to establish the use of a standardised protocol across sites. Then to investigate the use after one cycle of FDG SUV max avidity change in predicting response and duration of treatment. We have established a working committee with the Netherlands trial group, whose trial is the use of nitroglycerin with Paxlitaxel, Carboplatin/Bevacizumab to establish a meta-analyses of the two trial data sets when both trials are completed. Study Chair: Andrew Davidson andrew.davidson@health.wa.gov.au CTC Trial Coordinator: Nick Muljadi nitro@ctc.usyd.edu.au The results of an interim analysis were released in May 2011 which showed a lack of efficacy and increased toxicity in the treatment group, thus a decision was made by the data safety management committee to stop the trial and unblind all patients. Patients who were on the cediranib at the time of unblinding were given the option of continuing after discussion with the investigator. A final analysis will occur in September 2011, after which trial sites will close. Publication of the study results is anticipated in 2012 Study Chair: Dr. Ben Solomon ben.solomon@petermac.org CTC Project Manager: Eric Tsobanis BR.29@ctc.usyd.edu.au : A/Prof Martin Stockler CTC Clinical Lead Tel: martin.stockler@sydney.edu.au Xanthi Coskinas CTC Assoc. Program Mgr Tel: Xanthi.coskinas@ctc.usyd.edu.au Eric Tsobanis Project Manager Tel: eric.tsobanis@ctc.usyd.edu.au Prunella Blinman CTC PhD Student Tel: prunella.blinman@ctc.usyd.edu.au Nick Muljadi CTC Trial Coordinator Tel: Chris Brown CTC Statistician Tel: chris.brown@ctc.usyd.edu.au Lucille Sebastian CTC Trial Coordinator Daniel Obanda CTC Trial Coordinator Tel:

4 Page 4 ALTG 04/009 - PACT in NSCLC Study Preferences for adjuvant chemotherapy in non-smallcell lung cancer: What makes it worthwhile to patients and their doctors? The PACT in NSCLC study aims to determine the benefits judged necessary to make ACT worthwhile for patients with resected NSCLC and for doctors, the factors influencing their preferences, and patients preferred and experienced involvement in decision making. The recruitment target is 200 participants The inclusion criteria for this study are as follows: 1. Stage I-III non-small cell lung cancer resected within the last 12 weeks 2. Referred to a participating medical oncologist for consideration of post-operative ACT 3. Able and willing and to complete study questionnaires 4. Written, informed consent The exclusion criteria are: 1. Evidence of distant metastatic disease 2. Previous chemotherapy for lung cancer Canberra Hospital (3) Royal Prince Alfred Hospital (0) Royal North Shore Hospital (5) Coffs Harbour Base Hospital (3) Nepean Hospital (8) Port Macquarie Base Hospital (2) St Vincent s Hospital Melbourne (20) Nambour Hospital (3) The Prince Charles Hospital (19) Sir Charles Gairdner Hospital (4) Auckland Hospital (9) Royal Melbourne Hospital (2) Flinders Hospital (2) Christchurch Hospital (0) Concorde Hospital (0) An additional 2 sites are pending activation. Study Chair: Sue-Anne McLachlan Sue-Anne.MCLACHLAN@svhm.org.au CTC Trial Coordinator: Nick Muljadi lung_pt_pact@ctc.usyd.edu.au There are 15 sites activated with 80 patients enrolled: ALTG 08/001 - Physical Activity in Lung Cancer trial (PAL) Advanced lung cancer results in significant physical and psychological symptoms leading to poorer quality of life. Fatigue is the most common and distressing patient-reported symptom. The PAL study is a randomized control trial which aims to evaluate the effects of a structured physical activity program on fatigue and quality of life for people with advanced lung cancer (NSCLC, SCLC). Participants are randomized to either the usual standard of care or an 8-week physical activity program, which consists of a combination of home-based and supervised exercise sessions. The supervised sessions also include a behavioural change component to help promote the adoption and maintenance of physical activity. The inclusion criteria for the study are as follows: 1. Non-resectable residual lung cancer (NSCLC, SCLC) Curative intent > 4 weeks post treatment Palliative intent: can be on active treatment 2. Age > 18 years 3. Medically fit to participate in a physical activity program 4. ECOG performance status of >3 5. English proficiency 6. Life Expectancy > 6 months Recruitment The study opened in July 2009 and there are 4 active hospital sites. A total of 46 participants have been randomized; 25 from Concord Hospital, 15 from Royal Prince Alfred Hospital, 5 from Westmead Hospital and 1 from Prince of Wales Hospital. Efforts continue to focus on participant recruitment, as a total of 140 participants are required. A/Prof Janette Vardy (PI) - janette.vardy@sydney.edu.au Haryana Dhillon (PI) - haryana.dhillon@sydney.edu.au Anna Jones (Study Coordinator) - a.jones@sydney.edu.au ALTG 09/006 - Unmet Needs In Lung Cancer Patients and Carers This study titled "Caring for thoracic cancer caregivers: exploring psychological and supportive care needs" and involves interviewing bereaved carers of people with lung cancer to discuss their experience. The aim of the study is to identify intervention points for improving support of patients and carers during the lung cancer disease trajectory. The study has recruited 34 current caregivers to people with lung cancer and 8 bereaved carers from Concord Repatriation General, Royal Prince Alfred, and Prince of Wales Hospitals. Study recruitment and data collection will be complete by mid-october 2011 to allow analysis prior to the Clinical Oncological Society Annual Scientific Meeting, where the first study results will be given as an oral presentation. Haryana Dhillon (Co-PI) Haryana.dhillon@sydney.edu.au Melanie Price (Co-PI) Melanie.price@sydney.edu.au Janette Vardy (Co-PI) janette.vardy@sydney.edu.au

5 Page 5 ALTG 09/004 - B2P2M2 B2P2M2 is a single arm phase II trial of BNC105P as second line chemotherapy after pemetrexed and a platinum in patients with advanced malignant pleural mesothelioma. BNC105P is a novel, intravenous tubulin polymerase inhibitor with direct cytotoxicity and vascular disrupting effects, which has shown some activity against MPM in a recent phase I trial. It was developed by Bionomics Ltd, an Australian biotech company. The trial is coordinated by the NHMRC Clinical Trials Centre under the auspices of the Australasian Lung cancer Trials Group. Primary Objective: To determine the objective tumour response rate (CR or PR) according to RECIST modified for mesothelioma Secondary Objectives: Progression free-survival (PFS progression or death), Treatment duration (TD time from first dose to last dose), Adverse events (grades 1-5) according to NCI CTCAE v 4.0, Effects on health-related quality of life, Changes in lung function (FEV1 and FVC), Overall survival (OS death from any cause). Trial Schema: All patients will be given BNC105P 16 mg/m2 given intravenously on days 1 and 8 of 21 day cycles repeated until progression or prohibitive toxicity. 24 evaluable patients required for stage 1 and 55 evaluable patients for Stage 2. Brief update: The trial completed stage 1 with 30 patients accrued. The first interim analysis was recently completed which informed the Trial Management Committee that the study threshold of at least 2 responses in the 24 evaluable patients had not been met. There the Trial Management Committee decided that the study will not be progressing to stage 2. Patients on the study will be followed up for a minimum of 6 months and then the study will close. Thank you to all the sites who contributed to stage 1, your efforts have been greatly appreciated. Sites that participated in stage 1 were: Port Macquarie Base Hospital (1) Sir Charles Gairdner Hospital (8) Royal North Shore Hospital (3) Concord Hospital (0) Ashford Cancer Centre (1) Royal Prince Alfred Hospital (2) The Prince Charles Hospital (8) Nepean Hospital (2) Prince of Wales Hospital (0) Flinders Medical Centre (0) Austin Hospital (4) Monash Medical Centre (1) Study Chair: Anna Nowak anowak@meddent.uwa.edu.au CTC Trial Coordinator: Lucille Sebastian b2p2m2@ctc.usyd.edu.au ALTG 09/002 - BR26 BR26 is a randomised, double-blind, placebo-controlled trial of PF-804, an orally available, potent, and highly selective irreversible EGFR TKI, in patients with incurable stage IIIB/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease. This multicentre, international phase III trial is being coordinated by the NCIC Clinical Trials Group in collaboration with the NHMRC Clinical Trials Centre and Australasian Lung cancer Trials Group. The study received Central Ethics Committee approval in New South Wales in December 2009, and in Victoria in May Royal Prince Alfred Hospital was the first Australian site to open in May Since then 15 additional sites have opened and 43 patients have been recruited as follows: Royal Prince Alfred Hospital, NSW (10) Monash Medical Centre, VIC (4) Royal Adelaide Hospital, SA (4) Sir Charles Gairdner Hospital, WA (3) Prince of Wales Hospital, NSW (3) Calvary Mater Newcastle Hospital, NSW Peninsula Oncology Centre, VIC (4) The Prince Charles Hospital, QLD (3) St. George Hospital, NSW (5) Nambour Hospital, QLD Royal North Shore Hospital, NSW Concord Repatriation General Hospital, NSW (1) Austin Hospital VIC Western Hospital VIC (1) Auckland City Hospital, NZ (4) Peter McCallum Cancer Institute, VIC The remaining 2 sites (Geelong Hospital, VIC) and Westmead Hospital, NSW) are expected to open in December 2011 bringing the total number of sites to 18. Recruitment is expected to continue to September An interim analysis is expected March/April Study Chair: Professor Michael Millward millward@cyllene.uwa.edu.au CTC Project Manager: Eric Tsobanis BR.26@ctc.usyd.edu.au

6 Page 6 TROG CHISEL (ALTG 09/005) This study is a TROG study endorsed and co-badged by ALTG. The aim will be to recruit 100 evaluable patients. Seven sites have been activated and 17 patients randomized, with additional sites in Hobart, Melbourne, Perth, Newcastle and New Zealand planning to join the study in Funding has been obtained from CA for $260,000 per year for 3 years and a request has been made for an extension to mid-2012 due to delays in credentialing sites. (a) Randomisation to the experimental hypofractionated arm will be 2 to 1, so it is more likely that patients who consent will be allocated experimental treatment. (b) Patients randomized to the control arm do not need to be treated at a centre credentialed to deliver the experimental treatment; if centres do not have the technical capability of delivering the hypofractionated treatment their patients can be referred to a linked site if randomized to the experimental arm; if randomized to conventional treatment, it can be given at the base site. (c) A variation in fractionation has been allowed so that patients whose tumours are close to the chest wall can be given a lower dose of 4 x 12Gy; this is though to be safer in relation to chest wall injury. Any further enquiries regarding this Trial should be directed to the principal investigator, David Ball, at david.ball@petermac.org or the central trial coordinator, Gemma Tait at gemma.tait@petermac.org ALTG 11/003 ANTS 2 The Australian Neoadjuvant Therapy Trial (ANTS) is a randomized phase II clinical trial in patients with surgically resectable stage 1b IIIa non-small cell lung cancer. A total of 100 patients are randomized to receive prior surgery, 3 cycles of standard chemotherapy or the same chemotherapy plus cetuximab. This antibody binds the extracellular domain of the Epidermal Growth Factor Receptor. The chemotherapy regimen is cisplatin and pemexetred for patients whose tumours have non-squamous histology and cisplatin and gemcitabine for squamous cancers. The primary endpoint of the study is response rate as assessed by CT scan, while secondary endpoints include pathological response and PET scan response. Important Exploratory endpoints are molecular analyses of tumour tissue, normal tissues and circulating tumour DNA. This study initially opened at two sites as the ANTS trial, with a different chemotherapy schedule. The trial was put on hold pending resolution of support for the study, after one pharmaceutical company ceased support for the study and a second re-evaluated their strategy for their therapeutic agent. ANTS-2 now has support of two pharmaceutical companies, providing access to pemetrexed as well as cetuximab. The ANTS protocol has been modified to incorporate the change of chemotherapy and changes have been made to the selection criteria to facilitate patient enrolment. Currently site selection is in progress for ANTS-2, with replies from all but 2 proposed sites. The projected recruitment numbers from the sites allow for recruitment over months. Currently the contracts between the lead sites (Austin Health, Melbourne) and the 2 pharmaceutical companies are being arranged. Further enquiries shoud be directed to the Principal Investigator: Paul Mitchel paul.mitchel@austin.org.au Small cell lung cancer Concept Development Group Update A small cell lung cancer (SCLC) concept development group was formed in Q The Group has met via teleconference and face-to-face to discuss future SCLC trials for the ALTG. The working group comprises of medical and radiation oncologists interested in SCLC. The Group is currently working on the following concept: Temozolomide and PARP (Poly ADP ribose polymerase) inhibitor as second line chemotherapy for SCLC). The concept outline and schedule of assessments have been developed and now the Group is currently seeking funding to support this trial. Any further enquiries regarding this Trial should be directed to the principal investigator, Martin Stockler, at martin.stockler@sydney.edu.au ALTG 10/002 - A PILOT STUDY TO DEVELOP A CLASSIFICATION ALGORITHM FOR IDENTIFYING PATIENTS WITH ADENOCARCINOMA OF LUNG SUITABLE FOR INDIVIDUALIZED THERAPIES The primary objective is to retrieve archived slides and tissue blocks of 100 cases of lung adenocarcinoma diagnosed at SVH. Detailed histological classification, EGFR CISH testing and EGFR/KRAS mutational analysis will be performed. This information will then be correlated with clinical parameters. The results of this pilot study may inform the development of a protocol for a larger scale study to develop and validate a classification algorithm to include histopathology, EGFR GCN as detected by CISH, in addition to EGFR mutation analysis. Progress to date: Ethics approval obtained Top up funding ($17,000) obtained from a SVH Research Endowment Fund grant 100 archived slides and tissue blocks identified and retrieved. Detailed histological subtyping completed for 100 cases. Slides have been prepared for in-situ hybridization (ISH) EGFR gene copy number (GCN) and EGFR, KRAS and BRAF mutation testing EGFR, KRAS and BRAF mutation has been completed (Alex Dubrovic, PMCC) S-ISH EGFR GCN complete Sue-Anne McLachlan SVH sue-anne.mclachlan@svhm.org.au Other Investigators: Prue Russell, Gavin Wright, Matt Conron, Alex Dobrovic, ALTG

7 Page 7 ALTG 10/003 - Implementing standardised PET procedures for scanning, data collection and reporting in patients with NSCLC across Australia s ALTG sites: A feasibility study. A funding proposal for the inclusion of FDG PET scan in the NITRO study is being written to evaluate whether pre vs post chemotherapy of Metabolic Response using Flurodeoxyglucose Positron Emission Tomography (FDG-PET) in Non Small Cell Lung Cancer within the ALTG NITRO trial can predict response and time on treatment. In 2011 a questionnaire sent to seven nominated ALTG sites across states has identified that there are differences in PET protocols across different sites, with the most common variations seen in diabetic patient preparation, hydration protocols, sedation, variation in time between injection and imaging, administered dose and camera hardware and software differences (time of flight, reconstruction algorithms). Sites have agreed that they would be supportive of a standardised PET protocol, similar to the EANM guidelines, for the purposes of cross-centre comparison as part of an ALTG supported multicentre clinical trial. The questionnaire also determined that all 7 sites would be capable of the required image acquisition, reconstruction and analysis required for a multicentre study. Several sites indicated a preference for centralised semiquantitative data analysis for response assessment. The process and cost to standardise across sites and the establishment of funding to run the trial is being sought from Australian funding sources. Contact Andrew Davidson Andrew.Davidson@health.wa.gov.au ALTG 10/004 - Limiting the functional decline of patients with advanced non-small cell lung cancer. The functional decline that is seen in patients with lung cancer is a complex issue. It is well recognised by treating clinicians that patients with advanced NSCLC decline physically over time but has been poorly studied to date. Phase 1 (40 participants) of this study looked at this in detail and showed that patients with advanced stage disease have clinically significantly lowered physical function at commencement of treatment and participants function continued to decline over time. The aim of this project (phase 2) is to pilot test a home based exercise program, designed to lessen the functional decline and its impact on patients. The home exercise program is based on pulmonary rehabilitation principles. The objective is to assess the feasibility and acceptability of the pilot intervention in ten participants to further refine the model before undertaking a larger randomised control trial. Functional and QOL assessment measures are carried out prior to beginning treatment. Participants then begin the 6 week exercise program while undergoing treatment and are then followed up at 2 months, 4 months and 6 months. Recruitment for the study began in February 2011 at Peter MacCallum Cancer Centre (East Melbourne). To date 9 participants have been recruited into the project. Study contacts: Dr Linda Mileshkin (PI). linda.mileshkin@petermac.org Andrew Murnane (Study Coordinator) andrew.murnane@petermac.org ALTG 11/001 MASTERY The MASTERY study is a proposed ALTG multicentre randomised phase II clinical trial of sunitinib or placebo as maintenance therapy in malignant pleural mesothelioma. Currently, there is no standard second-line or maintenance therapy for this disease. A previous single arm phase II study of sunitinib as second line therapy for mesothelioma showed activity, with 12% partial response and 65% stable disease as best response. On the basis of this, the MASTERY trial has been designed to evaluate the use of maintenance sunitinib in patients with ECOG PS 0-1 following response or stable disease at the completion of platinum and pemetrexed first-line therapy. Patients will be randomised to either oral sunitinib 37.5mg daily continuous therapy, or identical placebo, following determination of stable disease or partial response at the end of chemotherapy. The primary endpoint is progression-free survival. Secondary endpoints include objective radiological response, quality of life, toxicity and adverse events, change in serum mesothelin, and overall survival. Biospecimens will be taken for exploratory endpoints, including VEGFR polymorphisms. A draft protocol was developed at the 2011 Flims clinical trials workshop and a proposal submitted to Pfizer Australia and Pfizer International. Unfortunately Pfizer are unable to provide funding to conduct the study but would be agreeable to supply study drug should funding be received from competitive sources. Submission for Cancer Australia/NHMRC funding is being considered for the 2012 round. Study Chair: Anna Nowak anowak@uwa.edu.au

8 We re on the Web! The Australasian Lung cancer Trials Group (ALTG) is Australia and New Zealand's lung and thoracic cancer clinical research group. The ALTG is a multi-disciplinary organization dedicated to reducing the incidence, morbidity and mortality of lung and thoracic cancer and improving the quality of life of lung and thoracic cancer patients in Australia and New Zealand through the coordination and facilitation of high quality clinical research. The ALTG collaborates with a number of organizations including the NHMRC Clinical Trials Centre (CTC) and Peter MacCallum Cancer Centre. Both of these groups are leaders in Australia for the design, conduct, analysis and publication of oncology clinical trials, including working with both Australia and international collaborative groups. The specific objectives of the ALTG are: To facilitate participation in the development, conduct, evaluation, reporting of clinical trials in lung and thoracic cancer. To promote the use of clinical trials in evaluating new treatments and management approaches for lung and thoracic cancer. Business Address: Australasian Lung cancer Trials Group c/o The Australian Lung Foundation 44 Brookes Street Bowen Hills QLD 4006 Mailing Address: Australasian Lung cancer Trials Group c/o The Australian Lung Foundation PO Box 847 Lutwyche QLD 4030 Telephone: 61 (0) Fax: 61 (0) nigel@lungfoundation.com.au The ALTG is generously supported through unrestricted educational grants from the following companies:

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