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Study of Tarlatamab Treatment for Patients with Small Cell Lung Cancer Who Have Not Responded to Two or More Previous Treatments

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 study focuses on Small Cell Lung Cancer (SCLC) that has returned or stopped responding to previous treatments. The research evaluates a new medication called tarlatamab (also known as AMG 757) in patients who have already undergone at least two different treatments, including one that contained platinum-based therapy. The purpose is to assess how well tarlatamab works and how safe it is for treating this type of lung cancer.

The treatment involves receiving intravenous infusions of tarlatamab, which is given as a powder that is mixed into a solution before administration. The study consists of three parts, with different doses of the medication being tested. During treatment, doctors will monitor how the cancer responds to the medication and track any side effects that may occur.

Patients may continue receiving the treatment for up to 24 months, as long as their cancer does not worsen and they do not experience unacceptable side effects. Throughout the study, doctors will perform regular assessments to measure how well the treatment is working, including checking if tumors have shrunk or disappeared, how long any improvements last, and how long patients survive without their cancer getting worse.

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 assessment

    Your doctor will perform measurements of your measurable lesions within 21 days before starting the treatment

    Medical tests will check your blood counts, liver function, kidney function, heart function, and lung function to ensure you can safely participate

  2. Step 2

    Treatment preparation

    A tumor tissue sample will be required - either from previous procedures or through a new biopsy

    If you have treated brain metastases, they must be stable and symptom-free for at least 7 days before starting treatment

  3. Step 3

    Treatment administration

    Tarlatamab will be given through an intravenous infusion (directly into your vein)

    The medication comes as a powder that will be prepared as a solution for your infusion

    Your treatment will continue until October 2025 or earlier if specified by your doctor

  4. Step 4

    Monitoring during treatment

    Regular assessments will track how your cancer responds to treatment

    Your doctor will monitor for any side effects

    Blood samples will be taken to measure drug levels and check for antibodies against the medication

    Imaging scans will be performed to evaluate your response to treatment

  5. Step 5

    Response evaluation

    Your response to treatment will be assessed using specific criteria called RECIST 1.1

    The evaluation will look for complete response (total disappearance of cancer), partial response (shrinkage of cancer), or disease control

    The length of time your cancer responds to treatment will be measured

Who can join the trial?

17 criteria

  • Must be at least 18 years old
  • Must provide informed consent before any study procedures begin
  • Must have confirmed small cell lung cancer that has returned or not responded to previous treatments
  • Must have previously received treatment with platinum-based chemotherapy and at least one other therapy type
  • Must have adequate organ function including:
    • Healthy blood cell counts
    • Normal blood clotting function
    • Adequate kidney function
    • Sufficient liver function
    • Normal breathing capacity
    • Heart function with ejection fraction of at least 50%
    • Must be willing to provide a tumor tissue sample or undergo a tumor biopsy if needed
    • Must have a good physical condition (ECOG performance status of 0 or 1, meaning able to perform daily activities with minimal assistance)
    • Must have a life expectancy of at least 12 weeks
    • Must have measurable tumors that can be evaluated by imaging
    • If brain metastases (spread of cancer to brain) are present, they must be:
      • Previously treated and stable
      • Not causing symptoms for at least 7 days
      • Not requiring steroid treatment (except for standard maintenance doses)

Who cannot join the trial?

12 criteria

  • Prior history of central nervous system metastases (cancer that has spread to the brain or spinal cord), unless treated and stable for at least 2 months
  • History of another type of cancer in the past 2 years, except for adequately treated non-melanoma skin cancer or cervical cancer in situ
  • Current participation in other clinical trials or treatment with investigational drugs within 28 days before starting this study
  • Significant heart conditions including:
    • Uncontrolled high blood pressure
    • Heart attack within the past 6 months
    • Unstable heart rhythm problems
    • Active or chronic infections including hepatitis B, hepatitis C, or HIV
    • Severe liver problems or abnormal liver function tests
    • Severe kidney problems or significantly reduced kidney function
    • Any condition that, in the investigator's opinion, would interfere with the patient's ability to participate safely in the study
    • Pregnancy or breastfeeding
    • Unable or unwilling to use effective contraception during the study period
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Investigated drugs

Tarlatamab is an investigational medication being studied for the treatment of small cell lung cancer in patients who have already tried at least two other treatments that didn't work well enough. It's a new type of therapy that works by targeting specific proteins found on cancer cells. The medication is designed to help the body's immune system recognize and fight cancer cells. The drug is administered to patients to evaluate how well it works in treating their cancer, how safe it is to use, and how the body processes it.

What is already known about the treatment

Tarlatamab - An investigational bispecific antibody being studied in clinical trials for the treatment of relapsed or refractory small cell lung cancer in patients who have received two or more prior lines of treatment. The medication is administered through intravenous infusion and works by targeting both DLL3 (Delta-like ligand 3) on tumor cells and CD3 on T-cells, creating a bridge that helps the immune system attack cancer cells. As a novel immunotherapy agent, tarlatamab represents a targeted approach in oncology treatment, with ongoing phase 2 clinical trials evaluating its efficacy, safety, tolerability, and pharmacokinetic properties in cancer patients.

Investigated diseases

Small Cell Lung Cancer - A fast-growing type of lung cancer that typically starts in the bronchi (airways) of the lungs. The cancer cells are small and oval-shaped when viewed under a microscope, which gives this type of cancer its name. It tends to spread rapidly through the bloodstream and lymphatic system to other parts of the body. The disease often develops in the central part of the lungs and can create large tumors that grow quickly. Small cell lung cancer usually occurs in clusters of cancer cells, which can cause hormonal syndromes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511837-37-00Protocol code20200491Estimated enrolment209 patientsSponsorAmgen Inc.

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