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Study of Tarlatamab for Patients with Metastatic or Advanced Small-Cell Lung Cancer and Neuroendocrine Carcinomas

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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 effects of a treatment called Tarlatamab (also known by its code name AMG 757) in patients with certain types of cancer. The cancers being studied are Metastatic Small-Cell Lung Cancer and other types of Poorly Differentiated Neuroendocrine Carcinomas. These are serious conditions where cancer cells have spread to other parts of the body or are not well-defined under a microscope.

The purpose of the study is to understand how well Tarlatamab works in treating these cancers. Tarlatamab is a special type of treatment known as a bispecific T-cell engager (BiTE) molecule, which is designed to help the body's immune system target and fight cancer cells. The study will involve giving the treatment to patients through an intravenous infusion, which means it will be administered directly into the bloodstream. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects.

Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. This includes looking at how the cancer responds to the treatment and any side effects that may occur. The study aims to gather information on how effective Tarlatamab is in treating these types of cancer and to better understand the body's response to the treatment. The study will also include biomarker analysis, which involves studying certain biological markers in the body to understand how they relate to the treatment's effectiveness and any resistance that may develop.

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

    Initial visit

    Upon joining the study, a comprehensive initial visit is conducted. During this visit, a series of assessments are performed to ensure eligibility. These include a review of medical history, a physical examination, and laboratory tests to confirm adequate bone marrow reserve and organ function.

    A baseline oxygen saturation test is conducted to ensure it is greater than 90% on room air. Female participants undergo a serum pregnancy test to confirm a negative result. Consent forms are signed to confirm understanding and agreement to participate in the study.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of the study medication, tarlatamab. This medication is provided as a powder for solution for infusion and is administered through an intravenous route.

    The dosage, frequency, and duration of administration are determined by the study protocol and are explained during the initial visit. Participants are monitored closely for any side effects or reactions during and after the infusion.

  3. Step 3

    Ongoing assessments

    Throughout the study, regular assessments are conducted to monitor health and response to the treatment. These include blood tests, imaging studies, and physical examinations.

    Participants are required to undergo tumor and blood biopsies at specified intervals: before treatment, during treatment, and at the end of treatment. These biopsies help in analyzing the response or resistance to the medication.

  4. Step 4

    Follow-up visits

    Follow-up visits are scheduled to evaluate the effectiveness of the treatment and to monitor for any long-term effects. These visits include a review of any side effects experienced and adjustments to the treatment plan if necessary.

    Participants are encouraged to report any new symptoms or concerns during these visits to ensure comprehensive care and management.

  5. Step 5

    End of treatment

    At the conclusion of the treatment phase, a final assessment is conducted. This includes a thorough evaluation of the treatment's impact on the condition and any side effects experienced.

    Participants are provided with guidance on post-study care and any necessary follow-up actions. The study team remains available for any questions or concerns that may arise after the study ends.

Who can join the trial?

17 criteria

  • Must be at least 18 years old.
  • Must have a tumor that can be easily accessed for a biopsy, which is a procedure to take a small sample of tissue for testing. Bone biopsies should be avoided if possible. Must agree to have biopsies and blood tests before, during, and after treatment.
  • Must have enough healthy bone marrow and properly working organs, based on recent lab tests.
  • Must have an oxygen level in the blood of more than 90% when breathing normal air.
  • Women who can have children must have a negative pregnancy test before starting and must agree to use effective birth control or avoid sex during the study and for at least 60 days after the last dose of the study drug.
  • Women must not donate or collect eggs for personal use during the study and for at least 60 days after the last dose of the study drug.
  • Men must either be surgically sterile, avoid sex with women, or agree to use effective birth control during the study and for at least 60 days after the last dose of the study drug.
  • Men must not freeze or donate sperm during the study and for at least 60 days after the last dose of the study drug.
  • Must understand and sign a consent form before any study-specific procedures are done. Must be willing and able to attend study visits and follow procedures.
  • Must be part of a Social Security System or have similar benefits.
  • Must have a confirmed diagnosis of metastatic or locally advanced small cell lung cancer (SCLC) or other poorly differentiated neuroendocrine carcinomas (NECs) with specific characteristics based on recent biopsy results.
  • For certain types of cancer, the initial biopsy must be reviewed by a specialist. The tumor must meet specific criteria, such as a high level of cell division or specific genetic markers.
  • Must have been treated with at least one previous therapy, including a platinum-based treatment, and have shown progression after standard treatment. Previous treatment with certain immune therapies is allowed.
  • For certain prostate cancer patients, must continue hormone therapy during the study.
  • Must have an ECOG performance status of 0, 1, or 2, which is a scale used to assess how the disease affects daily living abilities.
  • Must have a life expectancy of at least 3 months.
  • Must have at least one tumor that can be measured by imaging tests according to specific criteria.

Who cannot join the trial?

3 criteria

  • Patients with other types of cancer that are not metastatic small cell lung cancer (SCLC) or poorly differentiated neuroendocrine carcinomas (NECs) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Tarlatamab (AMG 757) is a medication being studied for its potential to treat certain types of cancer, specifically small-cell lung cancer and other similar cancers that are difficult to treat. It works by helping the body's immune system recognize and attack cancer cells. This medication is part of a clinical trial to see how well it can help patients with these types of cancer and to understand how the body responds to it.

What is already known about the treatment

Tarlatamab (AMG 757) – Tarlatamab is administered as an injection, typically given in a clinical setting by healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating metastatic small cell lung cancer (SCLC) and other poorly differentiated neuroendocrine carcinomas (NECs). The medication works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. Tarlatamab is classified as a bispecific T-cell engager, a type of immunotherapy that aims to boost the body's natural defenses against cancer.

Investigated diseases

  • Metastatic Small Cell Lung Cancer (SCLC)

    This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It often begins in the bronchi and can spread rapidly to other parts of the body, including the lymph nodes, liver, bones, and brain. The disease progresses through stages, starting from limited to extensive, where cancer cells have spread beyond the lungs. SCLC is known for its aggressive nature and rapid growth. As it advances, symptoms may include coughing, chest pain, and difficulty breathing. The disease can also cause paraneoplastic syndromes, which are conditions triggered by the immune system's response to the cancer.

  • Poorly Differentiated Neuroendocrine Carcinomas (NECs)

    These are a group of aggressive cancers that originate from neuroendocrine cells, which are found throughout the body. These cells have traits of both nerve cells and hormone-producing cells. NECs are characterized by their rapid growth and tendency to spread quickly to other organs. The disease can occur in various parts of the body, including the lungs, gastrointestinal tract, and pancreas. As the cancer progresses, it may cause symptoms related to the overproduction of hormones, such as flushing or diarrhea, as well as symptoms from tumor growth, like pain or obstruction. The progression of NECs is typically fast, with a high potential for metastasis.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515847-47-00Protocol codeCSET 2024/4014Estimated enrolment41 patientsSponsorInstitut Gustave Roussy

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