The UK, through the National Cancer Research Institute (NCRI) Neuroendocrine Subgroup, is able to offer access to clinical trials to patients diagnosed with neuroendocrine tumours. It is important to note that the term “neuroendocrine tumours” refers to many types of NETs and clinical trials are tailored to address a specific scientific question within a particular type, stage and activity of NET. Therefore an individual patient may be eligible for one or more trials at a time, or none.
If you wish to see the portfolio map of clinical trials in NETs, please follow the NCRI link: http://csg.ncri.org.uk/portfolio/portfolio-maps/ and select “Upper gastro-intestinal cancer” where you will find “Map B – Neuroendocrine”
Follow the NCRI link given for each study for more details of the clinical trial (including inclusion and exclusion criteria) and contact details. Where available, links to the clinicaltrials.gov database are also provided.
Open studies (in alphabetical order)
Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence
This is an international study involving the USA, Canada, France, Germany, Italy, Netherlands and the UK. It is evaluating the effectiveness of a chemotherapy drug called mitotane in reducing the chances of disease relapse after patients have had potentially-curative surgery of adrenal cancer (adrenocortical carcinoma).
Recruiting UK site: Queen Elizabeth Medical Centre, Birmingham
Efficacy and safety of Lanreotide Autogel 120 mg administered every 14 days in well-differentiated, metastatic or locally-advanced, unresectable pancreatic or midgut neuroendocrine tumours, having progressed radiologically while previously treated with Lanreotide Autogel 120 mg administered every 28 days
A previous study (CLARINET) has shown that lanreotide, given every 4 weeks, delays the growth of neuroendocrine tumours of the pancreas or mid-gut. In time, the tumours will get larger; this study is evaluating how effective lanreotide is when the injection interval is then reduced to 2-weekly (i.e. two injections per month, instead on once a month) in such patients.
Recruiting UK sites: Queen Elizabeth Medical Centre, Birmingham; Royal Free Hospital, London; and The Christie, Manchester
FETONET | UK CI Rohini Sharma [NCRI ID 15548]
Evaluation of [ 18 F]fluoroethyl triazole labelled [Tyr 3 ]Octreotate analogue for the imaging of Neuroendocrine tumours
The use of nuclear imaging is well-established in patients with NETs; octreotide scans and 68-Gallium PET scans are most commonly used. In this study, a novel tracer is being evalu- ated called [18F]fluoroethyl triazole labelled [Tyr3]Octreotate analogue ([18F]-FET-βAG- TOCA, for short). At this stage, this novel tracer does not replace the standard scans.
Recruiting UK sites: Imperial College, London
IMMUNET | UK CI Tim Meyer [NCRI link]
Systematic Evaluation of the Immune Environment of Neuroendocrine Tumours
This clinical trial is investigating how the immune system responds to neuroendocrine cancers and aims to provide a scientific rationale that will lead to clinical trials of immunotherapy in this group of patients. The study is open for patients with NETs due to commence systemic therapy (either for advanced disease or prior to potential surgery); fresh tissue biopsy and blood samples to characterise the diversity, quantity and quality of the immune cells infiltrating the NET.
Recruiting UK sites: Royal Free Hospital, London; Kings College, London; and The Christie, Manchester
PDR001| UK PI Chrissie Thirlwell
Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)
This study is evaluating the immunotherapy drug PDR001 which blocks PD-1. The study is open for selected neuroendocrine tumours.
Recruiting sites: The Beatson, Glasgow and Royal Free, London
PEN-221 | UK PI Tim Meyer [NCT02936323]
PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers
This is first-in-human trial run in the UK and USA evaluating a new drug which is made of a somatostatin like peptide conjugated to the cytotoxic drug mertansine (DM1). The recommended dose has now been defined and the drug is being tested in pancreatic and midgut NET as well as small cell lung cancer.
Recruiting sites: UCLH, London and The Christie, Manchester
A European, multicentre, phase II/III randomised double-blind, placebo controlled study evaluating Lanreotide as maintenance therapy in patients with non-resectable duodeno-pancreatic neuroendocrine tumours after first-line treatment
This is an academic study led by colleagues in France assessing the effectiveness of lanreotide injections as a holding treatment (“maintenance”) following initial treatment (which may be either chemotherapy or a targeted-therapy, such as everolimus or sunitinib) in patients with well-differentiated neuroendocrine tumours of the pancreas or duodenum. Patients are randomised to receive either lanreotide or placebo.
Recruiting UK sites: Royal Free, London & The Christie, Manchester
Randomized phase III open label cross-over study to compare the efficacy and safety of everolimus followed by chemotherapy with STZ-5FU upon progression or the reverse sequence, chemotherapy with STZ-5FU followed by everolimus upon progression, in advanced progressive pNETs.
In this academic, ENETS-approved study, sponsored by the Spanish neuroendocrine group (GETNE) patients with well-differentiated pancreatic neuroendocrine tumours (pNETs) receive treatment with chemotherapy (streptozocin and 5-FU) and everolimus, one after the other. In the trial patients are allocated (at random, by chance) to either receive everolimus first (then chemotherapy) or chemotherapy first (then everolimus). The aim of the study is to evaluate whether there is a difference in outcome depending on the sequence of treatment.
SPINET | UK PI Martyn Caplin [NCT02683941]
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumors (SPINET)
This is an international Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of lanreotide plus best-supportive care (BSC) versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical lung NETs.
Recruiting sites: The Beatson, Glasgow, Royal Surrey, Guilford, Royal Free, London, Kings College, London, The Christie, Manchester, The Churchill, Oxford.