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Study Comparing 177Lu-Edotreotide and Everolimus for Patients with Neuroendocrine Tumors in the Lung and Thymus

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of treatments for patients with neuroendocrine tumors of the lung and thymus. These are a type of cancer that can occur in the hormone-producing cells of the lung and thymus. The study will compare two treatments: 177Lu-Edotreotide, a solution for injection or infusion, and Afinitor (everolimus), which is taken as a tablet. The purpose of the study is to see how well these treatments work in stopping the cancer from getting worse and to understand their safety and how they affect patients' quality of life.

Participants in the study will receive either 177Lu-Edotreotide or Afinitor. 177Lu-Edotreotide is given through an intravenous infusion, which means it is delivered directly into the bloodstream. Afinitor is taken orally as a tablet. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will last for a period of time, during which participants will be monitored regularly to assess the progression of their disease and any side effects they may experience.

The main goal of the study is to determine how long the treatments can prevent the cancer from progressing, which is known as progression-free survival. This will be measured from the time participants start the study until their disease shows signs of getting worse or they pass away. The study will also collect information on how the treatments impact the participants' daily lives and overall well-being. This information will help doctors understand which treatment might be more beneficial for patients with neuroendocrine tumors of the lung and thymus.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will either receive 177Lu-edotreotide or everolimus as part of your treatment plan.

  2. Step 2

    Treatment with 177Lu-edotreotide

    If you are assigned to the 177Lu-edotreotide group, you will receive this medication through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein.

    The specific dosage and frequency of the 177Lu-edotreotide infusions will be determined by the study team based on your individual needs and the study protocol.

  3. Step 3

    Treatment with everolimus

    If you are assigned to the everolimus group, you will take this medication in the form of a tablet. You will take a 10 mg tablet orally, which means you will swallow the tablet with water.

    The frequency and duration of taking everolimus will be specified by the study team, and you will be required to follow their instructions carefully.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health and response to the treatment will be closely monitored. This will involve regular visits to the study site for check-ups and assessments.

    You may undergo various tests and scans to evaluate the progression of your condition and the effectiveness of the treatment.

  5. Step 5

    End of study participation

    At the end of your participation in the study, you will have a final evaluation to assess your overall health and the outcomes of the treatment.

    You will receive guidance on any further steps or treatments that may be necessary after the study concludes.

Who can join the trial?

14 criteria

  • Must be 18 years of age or older.
  • Must have a type of cancer called a neuroendocrine tumor in the lung or thymus that is well to moderately differentiated.
  • Must have cancer that has spread (metastatic) or cannot be removed by surgery (locally advanced and unresectable).
  • Must have cancer that has shown growth in the last 12 months.
  • Must have cancer that can be measured by scans according to specific criteria (RECIST v1.1).
  • Must have a sample of the tumor tissue available for testing, either from a previous sample taken within the last 36 months or a new sample if possible.
  • Must have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have adequate function of organs and bone marrow, as shown by specific blood test results.
  • Women must have a negative pregnancy test and agree to use highly effective birth control during the study and for 6 months after the last dose of study treatment.
  • Women must agree not to breastfeed or donate eggs during the study and for 6 months after the last dose of study treatment.
  • Men must agree not to donate sperm and to use a condom or practice abstinence during the study and for 6 months after the last dose of study treatment.
  • Must not participate in another interventional study while in this study.
  • Must have cancer that is positive for somatostatin receptors on imaging tests.
  • Must have had no more than two previous systemic anti-cancer treatments.

Who cannot join the trial?

2 criteria

  • Patients who do not have well to moderately differentiated neuroendocrine tumors of the lung and thymus.
  • Patients who do not require systemic therapy. **Systemic therapy** means treatment that affects the entire body, not just one part.
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Investigated drugs

  • 177Lu-edotreotide

    is a type of therapy known as peptide receptor radionuclide therapy (PRRT). It is used to treat certain types of tumors that have specific receptors on their surface. This therapy involves using a radioactive substance that targets and binds to these receptors, allowing the radiation to directly affect the tumor cells. The goal is to slow down or stop the growth of the tumor by damaging the cancer cells with radiation.

  • Everolimus

    is a medication that works by blocking a specific protein in the body that helps cancer cells grow. It is used to treat various types of tumors by slowing down their growth and spread. Everolimus is taken orally and helps to control the disease by interfering with the cancer cells' ability to multiply. This medication is often used when other treatments have not been effective.

What is already known about the treatment

  • 177Lu-edotreotide

    This medication is administered through a method called peptide receptor radionuclide therapy (PRRT), which involves injecting the drug into the bloodstream. It is currently being studied for its effectiveness and safety in treating certain types of lung and thymus tumors that have specific receptors. The main use of 177Lu-edotreotide is to help manage neuroendocrine tumors that are positive for somatostatin receptors. At the molecular level, it works by binding to these receptors on tumor cells and delivering targeted radiation to destroy them. It is classified as a radiopharmaceutical, which means it combines a radioactive component with a drug to target cancer cells.

  • Everolimus

    This medication is taken orally in the form of a tablet. It is already used in medicine to treat various types of cancers and is being compared to 177Lu-edotreotide in clinical trials for its effectiveness in treating neuroendocrine tumors of the lung and thymus. Everolimus is primarily used to slow down the growth of cancer cells. It works by inhibiting a protein called mTOR, which is involved in cell growth and division. This medication is classified as an mTOR inhibitor, a type of targeted cancer therapy.

Investigated diseases

Neuroendocrine Tumors of the Lung and Thymus – Neuroendocrine tumors of the lung and thymus are a group of rare tumors that originate from neuroendocrine cells, which have traits similar to nerve cells and hormone-producing cells. These tumors can vary in their growth rate and are classified based on their differentiation, with well to moderately differentiated tumors being less aggressive. As they progress, these tumors may grow slowly and can spread to other parts of the body, although the rate of progression can vary significantly among individuals. Symptoms often arise from the tumor's location and may include coughing, chest pain, or difficulty breathing if located in the lung, or pressure symptoms if in the thymus. Hormonal symptoms can also occur if the tumor secretes hormones. The progression of these tumors is monitored through imaging and clinical evaluation to assess changes in size and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502154-13-00Protocol codeGETNE-T2217Estimated enrolment170 patientsSponsorGrupo Espanol De Tumores Neuroendocrinos

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