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Study of Tarlatamab for Patients with Limited-Stage Small-Cell Lung Cancer After Chemoradiotherapy

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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 a type of lung cancer known as Limited-Stage Small-Cell Lung Cancer (LS SCLC). The study will evaluate a treatment called Tarlatamab, which is a medication given through an infusion into the vein. Tarlatamab is being compared to a placebo to see how effective it is in preventing the cancer from getting worse after patients have already received a combination of chemotherapy and radiation therapy.

The purpose of the study is to compare the effectiveness of Tarlatamab with a placebo in patients who have not experienced cancer progression after their initial treatment. Participants in the study will receive either Tarlatamab or a placebo, and their health will be monitored over time to assess how well the treatment works in keeping the cancer from progressing. The study will involve regular check-ups and assessments to track the health and progress of the participants.

In addition to Tarlatamab, other medications such as Tocilizumab, Siltuximab, Buclizine Hydrochloride, Paracetamol, Codeine Phosphate, Argipressin, Mannitol, Betamethasone Sodium Phosphate, and Dexamethasone may be used in the study. These medications are used for various supportive care purposes and will be administered as needed. The study aims to provide valuable information on the potential benefits of Tarlatamab for patients with LS SCLC.

The research process

The trial runs in 6 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, informed consent is required. This means agreeing to participate after understanding the study details.

    Eligibility is confirmed based on criteria such as age, diagnosis of limited-stage small-cell lung cancer, and completion of prior treatments without disease progression.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either tarlatamab or a placebo. This is done to compare the effects of the medication against no active treatment.

  3. Step 3

    Treatment phase

    If assigned to the tarlatamab group, the medication is administered intravenously. The exact dosage and frequency are determined by the study protocol.

    Participants in the placebo group receive an intravenous solution that does not contain the active medication.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to monitor health status and any changes in the condition. This includes imaging tests and other evaluations.

    The primary goal is to assess progression-free survival, which means the length of time during and after treatment that the cancer does not worsen.

  5. Step 5

    Completion of treatment

    The treatment phase continues until specific criteria are met, such as disease progression or completion of the study duration.

    Participants are monitored for any side effects or adverse events throughout the study.

  6. Step 6

    Follow-up

    After completing the treatment phase, follow-up visits are scheduled to continue monitoring health and any long-term effects of the treatment.

Who can join the trial?

9 criteria

  • The patient must have given their agreement to participate in the study by signing a consent form.
  • The patient must be at least 18 years old, or older if the legal age in their country is higher.
  • The patient must have a confirmed diagnosis of **Small-Cell Lung Cancer (SCLC)** through specific medical tests.
  • The patient must have been diagnosed and treated for **Limited-Stage Small-Cell Lung Cancer (LS-SCLC)** with both chemotherapy and radiotherapy at the same time.
  • The patient must have completed the combined chemotherapy and radiotherapy treatment without the cancer getting worse, as determined by specific medical criteria called **RECIST 1.1**. This means the cancer is either completely gone (**CR**), has shrunk (**PR**), or has stayed the same (**SD**).
  • The patient must have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • The patient must have a life expectancy of at least 12 weeks.
  • The patient must have organs that are working well enough to participate in the study.
  • Any side effects from the previous chemotherapy and radiotherapy must have improved to a mild level, except for hair loss (**alopecia**) or tiredness (**fatigue**).

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides Limited-Stage Small-Cell Lung Cancer (LS SCLC) cannot participate.
  • Patients who have had previous treatments that might interfere with the study results are not eligible.
  • Patients with serious health conditions that could affect their safety during the trial are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with a history of allergic reactions to the study medication or similar drugs are excluded.
  • Patients who are currently participating in another clinical trial are not allowed to join this study.
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Investigated drugs

Tarlatamab is a medication being studied for its potential to treat small-cell lung cancer. It is being tested in patients who have a specific type of lung cancer called limited-stage small-cell lung cancer. These patients have already received a combination of chemotherapy and radiation therapy, and the study is looking at how well tarlatamab works in preventing the cancer from getting worse.

What is already known about the treatment

Tarlatamab – Tarlatamab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating limited-stage small-cell lung cancer (LS SCLC). It is in the experimental phase, with ongoing research to determine its efficacy and safety. The main therapeutic indication for tarlatamab is to prevent cancer progression in patients who have not shown disease advancement following chemoradiation therapy. At the molecular level, tarlatamab works by targeting specific proteins on cancer cells, helping the immune system recognize and destroy these cells. It is classified as an investigational immunotherapy agent.

Investigated diseases

Limited-Stage Small-Cell Lung Cancer – This is a type of lung cancer characterized by the rapid growth of small cells in the lung tissue. It is termed "limited-stage" when the cancer is confined to one side of the chest and can be treated with a single radiation field. The disease progresses quickly, often spreading to nearby lymph nodes and other parts of the body if not managed. Small-cell lung cancer is known for its aggressive nature and tendency to recur after initial treatment. It is less common than non-small cell lung cancer but is more responsive to chemotherapy and radiation therapy. The disease is often associated with smoking and can cause symptoms such as coughing, chest pain, and difficulty breathing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506235-15-00Protocol code20230016Estimated enrolment400 patientsSponsorAmgen Inc.

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