Clinical Trials for Neuroendocrine Carcinoma
This article provides information about 7 ongoing clinical trials for patients with neuroendocrine carcinoma. These studies are testing new imaging techniques, chemotherapy combinations, immunotherapy treatments, and targeted therapies for patients whose cancer has advanced or has not responded to standard treatments. Trials are taking place in Denmark, Italy, France, Spain, Germany, Poland, Belgium, Portugal, and Bulgaria.
Clinical trial locations
- Belgium
- Bulgaria
- 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
- France
- Germany
- Italy
- Poland
- Portugal
- Spain
Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms
This study is investigating how two different types of imaging scans can help predict disease progression in patients with neuroendocrine neoplasms affecting the digestive system or pancreas. The research uses specialized imaging substances to create detailed pictures of tumors.
Who can participate: Patients must be between 18 and 65 years old with a confirmed diagnosis of gastro-pancreatic neuroendocrine neoplasm through tissue examination. Participants need to have a WHO Performance status of 0-2, meaning they can care for themselves and perform light activities. Both men and women can join the study, and they must be able to read and understand the patient information and provide informed consent.
Who cannot participate: The study excludes patients under 18 or over 65 years of age, those unable to undergo PET/CT scanning, and individuals with known allergies to the imaging agents. Pregnant or breastfeeding women, people with severe claustrophobia, and those with metal implants that could interfere with imaging are not eligible. Patients who cannot lie still for 30-45 minutes during scanning or who have participated in another clinical trial within the past 30 days are also excluded.
Study focus: The main goal is to develop new ways to predict how long patients might remain stable without their disease getting worse by analyzing measurements from combined scans. Participants receive two imaging substances through intravenous injection on the same day: 64Cu-DOTATATE, which attaches to specific receptors found on these tumors, and 18F-FDG, which shows how active the tumor cells are. The combination provides doctors with more complete information about the tumor’s characteristics and behavior.
Investigational substances: 64Cu-DOTATATE is a radioactive tracer that specifically binds to receptors commonly found on neuroendocrine tumors, helping doctors visualize these tumors and their spread throughout the body. 18F-FDG (fluorodeoxyglucose) is also a radioactive tracer that shows areas in the body that use a lot of glucose, which is common in fast-growing cancer cells, helping doctors see how active the tumor cells are.
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 research combines two different imaging techniques to better understand how tumors use energy. The study includes patients with various types of cancer, including neuroendocrine neoplasms, and uses a combined PET/MR scanner to perform both scans simultaneously.
Who can participate: Adults 18 years or older with a confirmed diagnosis of neuroendocrine neoplasm (among other eligible cancers) can participate. The tumor must be at least 1.5 centimeters in size. Both men and women are eligible, and participants must not be part of any vulnerable population groups.
Who cannot participate: Patients under 18 or over 65 years old cannot participate. Those unable to lie still in the PET/MR scanner for up to 60 minutes, individuals with claustrophobia, or those with metal implants not compatible with MRI are excluded. Pregnant or breastfeeding women, patients with severe kidney dysfunction, and those with known allergies to the imaging substances are not eligible. Patients who have received other experimental drugs within 30 days, those who cannot provide informed consent, or those with uncontrolled medical conditions are also excluded.
Study focus: The trial aims to determine whether it is possible to perform both imaging methods at the same time to better understand how tumors use energy. Participants receive two different injectable substances through an intravenous line: Fluor-18-FDG and hyperpolarized pyruvate. This research will help doctors better understand how tumors process different nutrients and may lead to improved ways of detecting and monitoring cancer.
Investigational substances: Hyperpolarized [1-13C]Pyruvate is an imaging agent used in magnetic resonance spectroscopy that helps doctors see how cancer cells process nutrients differently from normal cells. 18F-FDG is a radioactive form of glucose used in PET imaging that helps doctors see areas where cells are using more glucose than normal, which is often a sign of cancer.
Study of daily low-dose Temozolomide in patients with advanced neuroendocrine tumors (NETs) who are not eligible for standard treatments due to their health condition
This trial is testing a continuous low-dose approach using Temozolomide for patients with advanced neuroendocrine neoplasms who cannot receive standard cancer treatments because of their health condition.
Who can participate: Patients must be over 18 years old with confirmed low-grade neuroendocrine tumors in the digestive system, lungs, or of unknown origin. The disease must be advanced and cannot be surgically removed or has spread to other parts of the body. Participants must have at least one of these conditions: reduced physical ability, low blood counts, moderate kidney or liver problems, serious additional health conditions, or previous treatment with more than 3 different anti-cancer therapies. The disease must show evidence of getting worse through scans.
Who cannot participate: Patients under 18 or over 65 years old are excluded, as well as those currently participating in other clinical trials within the last 30 days. Pregnant or breastfeeding women, patients receiving active antitumoral treatment, and those unable to provide informed consent cannot participate. People with severe psychiatric conditions, life expectancy less than 3 months, uncontrolled medical conditions, known allergies to study medications, or drug or alcohol abuse within the past 6 months are also excluded.
Study focus: The study examines how well low doses of Temozolomide work in preventing cancer progression in patients with advanced or spreading neuroendocrine neoplasms. The medication is given as oral capsules that patients can take at home. The treatment period may last up to 12 months with patients taking a daily dose. Researchers will monitor how the disease responds to treatment and track any side effects.
Investigational drug: Temozolomide is an oral chemotherapy medication that works by stopping cancer cells from growing and dividing. It belongs to a group of drugs called alkylating agents, which fight cancer by damaging the DNA of cancer cells. In this trial, it is being studied using a metronomic approach, meaning given in lower doses but more frequently.
Study on Durvalumab, Etoposide, and Platinum Drug Combination for First-Line Treatment of Advanced Large-Cell Neuroendocrine Lung Cancer Patients
This trial investigates a combination treatment for Large-Cell Neuroendocrine Carcinoma of the lung, a rare and aggressive type of lung cancer. The study tests whether combining immunotherapy with chemotherapy can help control the cancer.
Who can participate: Patients must be at least 18 years old with a confirmed diagnosis of Large-Cell NeuroEndocrine Carcinoma of the lung. The disease must be either locally advanced (Stage III) and not suitable for local treatment, or metastatic (Stage IV) and in the first line of treatment. Participants must have measurable disease according to specific medical guidelines, a Performance Status of 0 or 1, weigh more than 30 kg, and have a life expectancy of at least 12 weeks. Normal organ and bone marrow function is required, and participants must use highly effective birth control.
Who cannot participate: Patients who have received previous treatment for their lung cancer are excluded. Those with other types of cancer that are not under control, serious heart problems, active infections requiring treatment, or autoimmune diseases cannot participate. Pregnant or breastfeeding women, patients who have had an organ transplant, those with known allergies to the study drugs, or individuals with a history of drug or alcohol abuse that could interfere with the study are also excluded.
Study focus: The trial aims to determine how well this combination of drugs works as a first-line treatment and how long the treatment can keep the cancer from getting worse. Participants receive Durvalumab, Etoposide, and a platinum-based drug (either Cisplatin or Carboplatin) through intravenous infusion. Regular monitoring is conducted to assess effectiveness and check for side effects.
Investigational drugs: Durvalumab is a medication that helps the immune system fight cancer by blocking a protein that stops the immune system from attacking cancer cells. Etoposide is a chemotherapy drug that stops cancer cell growth by interfering with their DNA. Cisplatin and Carboplatin are platinum-based chemotherapy drugs that damage the DNA of cancer cells, preventing them from multiplying.
Study on Enfortumab Vedotin for Patients with Advanced Neuroendocrine Carcinoma Not Responding to or Ineligible for Platinum Chemotherapy
This trial is studying a medication called enfortumab vedotin for patients with advanced neuroendocrine carcinoma that has not responded to standard treatments or for patients who cannot receive platinum-based chemotherapy.
Who can participate: Patients must be 18 years of age or older with a confirmed diagnosis of neuroendocrine carcinoma that is poorly differentiated, or a well-differentiated neuroendocrine tumor of grade 3 with a Ki-67 index greater than 20%. The cancer can be from any origin except the lung and must have not responded to or be unsuitable for platinum-based chemotherapy. Participants must have metastatic or locally advanced disease, an ECOG score of 0-2, and evaluable or measurable disease by CT scan. Adequate kidney and liver function, a life expectancy of at least 12 weeks, and highly effective contraception measures are required.
Who cannot participate: Patients with lung neuroendocrine carcinoma or tumors are not eligible. Those who are eligible for first-line platinum-based chemotherapy or who have already responded well to first-line platinum-based chemotherapy cannot participate. Patients with a Ki-67 index of 20% or less are excluded.
Study focus: The trial evaluates how effective and safe enfortumab vedotin is when used alone in patients with advanced neuroendocrine carcinoma. The medication is given as an infusion directly into the bloodstream through a vein. The study will track how long patients live without the cancer getting worse and how long any positive response to the treatment lasts, while also collecting information on any side effects.
Investigational drug: Enfortumab vedotin is designed to target and deliver a cancer-fighting agent directly to the cancer cells. It works by targeting and binding to a protein called Nectin-4 on cancer cells, delivering a toxic agent that helps to kill the cancer cells. It is classified as an antibody-drug conjugate.
Study of Cabozantinib and Avelumab for Patients with Advanced Neuroendocrine Tumors G3 Resistant to Standard Chemotherapy
This study investigates a combination treatment using Cabozantinib and Avelumab for patients with advanced neuroendocrine neoplasias G3 whose cancer has not responded to standard chemotherapy.
Who can participate: Patients must be 18 years or older with a confirmed diagnosis of neuroendocrine neoplasia NEN G3. Participants must provide a sample of tumor tissue for testing and research. There should be no available treatment that can completely cure the condition. The cancer must have progressed after at least one round of chemotherapy and be measurable according to specific medical criteria. Patients must have adequate organ and bone marrow function and an ECOG Performance Status of 0-1.
Who cannot participate: Patients with small cell lung cancer or Merkel cell carcinomas are excluded from participation.
Study focus: The trial explores how effective and safe the combination treatment is for patients whose cancer has not responded to standard chemotherapy. Participants receive either the combination of Cabozantinib (taken as a tablet) and Avelumab (given as an infusion) or Avelumab alone. The study will last up to 12 months, with tumor assessments conducted every 8 weeks for the first 6 months and then every 12 weeks thereafter.
Investigational drugs: Cabozantinib is a medication that works by blocking certain proteins that promote cancer cell growth, helping to slow down or stop disease progression. Avelumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells by blocking the PD-L1 protein.
Study on BI 764532 for Patients with Relapsed or Refractory Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
This international trial is testing a treatment called BI 764532, a special type of medication known as a T cell engager, designed to help the body’s immune system target and fight cancer cells more effectively in patients whose cancer has returned or continued to grow after previous treatments.
Who can participate: Participants must be at least 18 years old (or the legal age of consent if higher) with a confirmed diagnosis of Small Cell Lung Cancer, extra-pulmonary neuroendocrine carcinoma (excluding certain types), or large cell neuroendocrine carcinoma of the lung. Patients with SCLC must have had at least two previous treatments, including one with a platinum-based drug. Those with other eligible types must have had at least one platinum-based treatment. Participants must have an ECOG score of 0 or 1, measurable tumors, and adequate organ function. Women who can have children and men who can father children must agree to use highly effective birth control methods.
Who cannot participate: Patients who have not experienced progression or recurrence after at least two previous treatments (for SCLC) or one treatment (for other eligible types) with platinum-based drugs cannot participate. Patients with types of cancer not specified in the study, such as Merkel cell carcinoma, medullary thyroid carcinoma, or neuroendocrine prostate cancer, are excluded.
Study focus: The trial evaluates the safety and effectiveness of different doses of BI 764532 in patients whose cancer has returned or continued to grow after previous treatments. The medication is given through an intravenous infusion, and participants will have regular check-ups and assessments to track their response to the treatment. Some participants may receive a placebo to compare the effects of the treatment.
Investigational drug: BI 764532 is designed to target a specific protein called DLL3, which is found on certain cancer cells. The medication works by engaging T cells, a type of immune cell, to attack and destroy these cancer cells. It is classified as a T cell engager, a type of immunotherapy.
Summary
These seven clinical trials represent a diverse range of research approaches for neuroendocrine carcinoma, spanning from advanced imaging techniques to novel treatment combinations. The trials are geographically distributed across Europe, with notable concentration in countries like France, Germany, Italy, and Spain. Several trials are multinational, particularly the BI 764532 study, which spans eight countries including Poland, Belgium, Portugal, and Bulgaria.
The research focuses on different aspects of disease management. Two Danish trials explore innovative imaging methods to better predict disease progression and understand tumor metabolism. Treatment-focused trials investigate various approaches: low-dose metronomic chemotherapy for patients who cannot tolerate standard treatments, combination immunotherapy with chemotherapy for first-line treatment, and targeted therapies for patients whose cancer has not responded to platinum-based chemotherapy.
A common theme across several trials is the focus on patients who have exhausted standard treatment options or whose cancer has proven resistant to platinum-based chemotherapy. The studies test both single agents and combination therapies, including immunotherapy drugs like Durvalumab and Avelumab, targeted therapies like Cabozantinib and Enfortumab Vedotin, and novel immune-engaging treatments like BI 764532. Most trials exclude specific subtypes of neuroendocrine cancer, such as small cell lung cancer or Merkel cell carcinoma, indicating the need for specialized research approaches for different disease presentations.
