Ongoing Clinical Trials for Neuroendocrine Tumours
There are currently 17 clinical trials investigating new treatments for neuroendocrine tumours across Europe. These studies are testing various therapies including targeted radiopharmaceuticals, imaging techniques, immunotherapy approaches, and chemotherapy combinations. Trials are being conducted in multiple countries including Italy, France, Spain, Belgium, Denmark, Netherlands, Germany, Sweden, Austria, and Poland.
Clinical trial locations
- Austria
- Belgium
- Denmark
- Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms
- Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas
- Study Comparing Dosimetry-Based PRRT and Standard Dose PRRT with Lutetium (177Lu) Edotreotide for Patients with Neuroendocrine Tumors
- France
- Study Comparing 177Lu-Edotreotide and Everolimus for Patients with Neuroendocrine Tumors in the Lung and Thymus
- Study on Retreatment with Lutetium (177Lu) Oxodotreotide for Patients with Intestinal Neuroendocrine Tumors
- Study on the Effectiveness of Etoposide, Carboplatin, and Cisplatin in Patients with Localized Digestive Neuroendocrine Carcinomas
- Study on the Effectiveness of Etoposide, Carboplatin, and Cisplatin in Patients with Localized Digestive Neuroendocrine Carcinomas
- Study on Long-term Safety of Satoreotide Tetraxetan Lutetium-177 for Patients with Somatostatin Receptor Positive Neuroendocrine Tumors
- Study on the Effectiveness of Lutetium (177Lu) Oxodotreotide and Octreotide in Patients with Advanced GEP-NET Tumors (Grade 2 and 3)
- Study on the Safety of Lutetium (177Lu) Oxodotreotide, L-Lysine Hydrochloride, and L-Arginine Hydrochloride in Adolescents with Neuroendocrine Tumors and PPGLs
- Germany
- Italy
See more trials
Study Comparing 177Lu-Edotreotide and Everolimus for Patients with Neuroendocrine Tumors in the Lung and Thymus
This clinical trial is comparing two different treatments for patients with tumours in the lung and thymus. One group receives 177Lu-Edotreotide, a radioactive solution given through a vein, while the other group takes Afinitor (everolimus) tablets by mouth.
Main inclusion criteria: Participants must be at least 18 years old and have well to moderately differentiated tumours that have spread or cannot be removed surgically. The cancer must have shown growth in the past 12 months and be measurable on scans. Patients need to have adequate organ and bone marrow function, confirmed through blood tests. Women must have a negative pregnancy test and agree to use effective birth control. The tumours must be positive for somatostatin receptors on imaging tests, and patients can have had no more than two previous systemic treatments.
Main exclusion criteria: Patients who do not have well to moderately differentiated tumours of the lung and thymus or who do not require systemic therapy (treatment affecting the entire body) cannot participate.
Trial focus: The study aims to determine how long the treatments can prevent cancer progression (progression-free survival) and to evaluate their safety and impact on quality of life. Participants undergo regular monitoring with assessments, scans, and quality of life questionnaires.
Investigational drugs: 177Lu-edotreotide is a peptide receptor radionuclide therapy that delivers targeted radiation to tumour cells with specific receptors. Everolimus works by blocking a protein called mTOR that helps cancer cells grow and multiply.
Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms
This Danish study uses advanced imaging techniques to predict how long patients might remain stable without their disease worsening. It combines two different types of scans using special imaging substances.
Main inclusion criteria: Patients must be between 18 and 65 years old and have a confirmed diagnosis of gastro-pancreatic neuroendocrine neoplasm through tissue examination. They must be able to provide informed consent and have a WHO Performance status of 0-2, meaning they can care for themselves with some limitations.
Main exclusion criteria: People outside the age range of 18-65 years, those unable to undergo PET/CT scanning, individuals with known allergies to the imaging agents, pregnant or breastfeeding women, those who cannot provide consent, and people with serious medical conditions that could interfere with participation are excluded. Participants who have been in another clinical trial within 30 days, have severe claustrophobia, metal implants that interfere with imaging, or cannot lie still for 30-45 minutes cannot join.
Trial focus: The study develops new ways to predict disease progression by analyzing combined scans. Participants receive injections of both 64Cu-DOTATATE and 18F-FDG on the same day, followed by PET/CT scans. Their health status is then monitored until December 31, 2026.
Investigational drugs: 64Cu-DOTATATE binds to receptors commonly found on neuroendocrine tumours, helping visualize their location. 18F-FDG shows areas using high amounts of glucose, indicating active tumour cells.
Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas
This Danish trial tests a new imaging method combining two different techniques to better understand how tumours use energy. It includes patients with various cancer types, including neuroendocrine neoplasms.
Main inclusion criteria: Participants must be adults (18 years or older) with a confirmed diagnosis of one of four cancer types: breast cancer, neuroendocrine neoplasm, lymphoma, or sarcoma. The tumour must be at least 1.5 centimeters in size.
Main exclusion criteria: People under 18 or over 65 years old, those unable to lie still in the scanner for up to 60 minutes, individuals with claustrophobia, people with metal implants incompatible with MRI, pregnant or breastfeeding women, those with severe kidney dysfunction, people with known allergies to the imaging substances, individuals who received other experimental drugs within 30 days, those unable to provide consent, people with uncontrolled medical conditions, those weighing more than 180 kg, or people with blood glucose levels above 200 mg/dL cannot participate.
Trial focus: The study evaluates whether both imaging methods can be performed simultaneously to better understand tumour metabolism. Participants receive intravenous injections of both substances and undergo imaging in a combined PET/MR scanner.
Investigational drugs: Hyperpolarized [1-13C]Pyruvate helps show how cancer cells process pyruvate differently from normal cells. 18F-FDG accumulates in cancer cells because they consume more glucose than healthy cells.
Study on Aldesleukin and Dendritic Cell Vaccine for Patients with Resected Stage IV Neuroendocrine Tumors and Soft Tissue Sarcoma
This Italian study tests an immunotherapy approach using a special vaccine made from the patient’s own tumour cells, combined with a protein that boosts the immune system.
Main inclusion criteria: Patients must have stage IV tumours that were completely removed by surgery and must be disease-free on scans done within 60 days before joining. They should have recovered from surgery side effects and be at least 18 years old with an ECOG performance status of 0 or 1. Adequate organ function is required, and patients 70 years or older must have a heart function test showing at least 55% ejection fraction. Tissue samples must be available for vaccine preparation.
Main exclusion criteria: Patients with other cancer types besides neuroendocrine tumours or soft tissue sarcoma, those not within the specified age range, and individuals from vulnerable populations cannot participate.
Trial focus: The study evaluates the safety and ability of the vaccine to stimulate the immune system against cancer cells. The vaccine (DC-VACCINE_IRSTIRCCS) is given through skin injections, while Proleukin (aldesleukin) is administered under the skin at a dose of 18 million international units.
Investigational drugs: Dendritic cells are taken from the patient’s body and loaded with material from their own tumour, helping the immune system recognize and attack remaining cancer cells after surgery.
Study on Continuing Somatostatin Analogues with Sunitinib, Octreotide, and Lutetium (177Lu) Oxodotreotide for Patients with Neuroendocrine Tumors
This Belgian-Dutch trial examines whether continuing somatostatin analogues when disease progresses can help delay further worsening of the condition.
Main inclusion criteria: Patients must be at least 18 years old with an ECOG performance status of 2 or less. They must have a confirmed diagnosis of locally advanced or metastatic, non-functional, well-differentiated WHO 2019 grade 1-2 GEP NET with documented disease progression on imaging despite first-line SSA treatment. For the targeted therapy arm, patients must have an indication to start sunitinib or everolimus as second-line therapy. For the PRRT arm, patients must have an indication to start PRRT with 177Lu-DOTATATE.
Main exclusion criteria: Patients with other cancer types, those who have not started second-line therapy, people not in the specified age range, vulnerable populations, and those unwilling or unable to follow study procedures are excluded.
Trial focus: The study has two parts: one examining effects when patients start PRRT as second-line treatment, and another when they start targeted therapy. It assesses whether continuing somatostatin analogues can delay disease progression and improve quality of life.
Investigational drugs: Somatostatin analogues mimic a natural hormone to slow tumour growth. PRRT uses radioactive material attached to a molecule targeting tumour cells. Targeted therapy medications interfere with cancer’s ability to grow and spread.
Study on Personalized vs Non-Personalized Radionuclide Therapy with 177Lu-Edotreotide and Capecitabine for Patients with Neuroendocrine Tumors
This Swedish trial compares personalized versus non-personalized treatment plans using 177Lu-Edotreotide to determine which approach works better.
Main inclusion criteria: Patients must have provided written informed consent and have advanced, well-differentiated, inoperable tumours confirmed by tissue sample, with a Ki67 index of 50% or less. They must be 18 years or older with an ECOG performance status of 0-1 and life expectancy exceeding 3 months. The tumour must show growth on scans within the last 1-24 months and demonstrate SSTR-expression at least twice as high as normal liver tissue on a 68Ga-DOTA-PET scan done within 3 months before starting. Adequate kidney function (GFR greater than 50 ml/min/1.73 m²), blood health, and liver function are required. All previous anti-tumour treatments except SSA must have stopped at least 4 weeks before starting.
Main exclusion criteria: Patients with other cancer types, those not SSTR-positive, people outside the specified age range, those unable to give informed consent, pregnant or breastfeeding women, people with severe medical conditions, recent participants in other trials, individuals with allergies to study medication, and those with a history of non-compliance are excluded.
Trial focus: The study monitors disease progression and side effects over treatment periods lasting up to 36 months for 177Lu-Edotreotide and up to 48 months for Capecitabine. Regular assessments include imaging tests like MRI or CT scans.
Investigational drugs: 177Lu-DOTATOC is a targeted therapy using a radioactive substance that targets tumour cells with specific receptors, delivering radiation directly to them while minimizing damage to healthy tissue.
Study on Retreatment with Lutetium (177Lu) Oxodotreotide for Patients with Intestinal Neuroendocrine Tumors
This French study evaluates the effectiveness of two additional cycles of Lutathera in patients who previously received similar treatment and are experiencing new tumour growth.
Main inclusion criteria: Patients must be at least 18 years old with measurable disease (at least one tumour 1 cm or larger and at least two tumours total). They need adequate blood cell counts (hemoglobin greater than 8 g/dl, neutrophils at least 1500 per mm³, platelets at least 80,000 per mm³). Women of childbearing potential must have a negative pregnancy test within 4 days before joining. Patients must have confirmed intestinal G1 or G2 tumours, previously received 4 cycles of Lutathera, maintained disease control for at least 12 months after first PRRT, and show disease progression after the first treatment. They must have ECOG performance status of 0-2, life expectancy of at least 6 months, and positive somatostatin receptor imaging within 4 months before joining.
Main exclusion criteria: Patients with different tumour types, those not previously treated with two cycles of Lutathera, people outside the specified age range, and vulnerable populations cannot participate.
Trial focus: The study compares two additional treatment cycles to active surveillance, evaluating disease control rate, safety, and quality of life. Participants receive one infusion every two months.
Investigational drugs: Lutathera delivers targeted radiation to cancer cells using lutetium-177 attached to a molecule binding specific tumour receptors, destroying cancer cells while minimizing healthy tissue damage.
Study on the Effect of Octreotide and Lanreotide in Peptide Receptor Radionuclide Therapy for Adults with Neuroendocrine Tumors
This Dutch trial studies how continued use of long-acting somatostatin analogs affects radiation absorption by tumours during PRRT.
Main inclusion criteria: Patients must be 18 years or older, able to provide spoken and written consent, and have a tumour confirmed by tissue examination. They must meet clinical criteria for PRRT and have at least one soft tissue lesion larger than 2 cm. The planned treatment involves 7400 MBq administered activity, and patients must have an ECOG score of 0 to 2.
Main exclusion criteria: People under 18, those without grade I or II tumours, and patients lacking clinical indication for PRRT cannot participate.
Trial focus: The study measures radiation absorbed by tumour lesions and normal tissues using SPECT/CT imaging, with blood samples taken to determine bone marrow dose and assist pharmacokinetic modeling.
Investigational drugs: Long-acting somatostatin analogues mimic somatostatin hormone action, lasting longer in the body to provide sustained effects in controlling tumour growth during PRRT.
Study Comparing Dosimetry-Based PRRT and Standard Dose PRRT with Lutetium (177Lu) Edotreotide for Patients with Neuroendocrine Tumors
This Danish trial compares personalized dosing based on individual needs versus standard dosing to determine if tailoring the dose can improve outcomes and reduce side effects.
Main inclusion criteria: Patients must be older than 18 years with tumours confirmed by histology. Their condition must have worsened despite standard treatments (somatostatin analogues, targeted therapy, or chemotherapy) or they experienced intolerable side effects. They need WHO/ECOG Performance Status of 0-2, life expectancy exceeding 6 months, and higher uptake than liver in primary tumour or metastases on Ga-DOTATOC PET/CT scan. Adequate organ function is required: kidney function (GFR greater than 30 ml/min), bone marrow function (WBC at least 2.0 x 109/L, platelets at least 100 x 109/L, hemoglobin at least 6 mmol/l), and willingness to attend scheduled visits.
Main exclusion criteria: Patients without neuroendocrine tumours, those outside the specified age range, and vulnerable populations are excluded.
Trial focus: The study randomly assigns participants to receive either dosimetry-based or standard dose PRRT, comparing progression-free survival, tumour radiation dose, and side effects, particularly kidney and bone marrow toxicity.
Investigational drugs: Lu-177-DOTATOC is a targeted radiation therapy where Lutetium-177 attaches to DOTATOC molecules, targeting and binding specific tumour receptors to directly affect cancer cells.
Study on the Effectiveness of Etoposide, Carboplatin, and Cisplatin in Patients with Localized Digestive Neuroendocrine Carcinomas
This French trial evaluates a 12-month chemotherapy treatment plan given before surgery to shrink tumours and improve disease-free survival.
Main inclusion criteria: Patients must have confirmed diagnosis of digestive neuroendocrine carcinoma with Ki 67 value greater than 20%. The cancer must be localized (confirmed by CT scan within 21 days before starting) with possible nearby lymph node involvement. PET and CT scans must confirm lymph node status with no secondary issues in other organs or bones. The tumour must be resectable as determined by a medical team. Patients must be at least 18 years old. Female patients need negative pregnancy test within 7 days before starting, and both men and women must use reliable birth control during the study and for 6 months after.
Main exclusion criteria: Patients with other cancer types, those who received other treatments, people with serious health conditions, those unable to follow procedures, pregnant or breastfeeding women, and people outside the specified age range are excluded.
Trial focus: The study monitors patients over 12 months, assessing how well chemotherapy prevents cancer return or spread. It includes regular imaging tests, analysis of cancer cell markers, and genetic information evaluation.
Investigational drugs: The chemotherapy combination (etoposide, carboplatin, and cisplatin) is given intravenously to target rapidly dividing cancer cells, disrupting their growth and replication.
Summary
The 17 ongoing clinical trials for neuroendocrine tumours demonstrate a strong focus on targeted radiopharmaceutical therapies, particularly those using lutetium-177 compounds. Several studies are concentrated in France, which hosts 7 trials, followed by Italy and Spain. A notable trend is the investigation of peptide receptor radionuclide therapy (PRRT) in various settings, including personalized dosing approaches, retreatment strategies, and combination with other medications. Multiple trials are evaluating lutetium-based therapies, suggesting this represents a major area of research interest for these rare tumours.
The trials span a range of disease stages and settings, from localized digestive carcinomas to advanced metastatic disease. Several studies specifically address paediatric and adolescent populations, recognizing the need for age-appropriate treatment approaches. Imaging studies using novel tracers aim to improve disease monitoring and treatment selection. The geographic distribution shows strong European collaboration, with some trials involving multiple countries simultaneously. Overall, these studies reflect ongoing efforts to refine treatment strategies, improve long-term outcomes, and better understand the safety profiles of emerging therapies for neuroendocrine tumours.
