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Study of tarlatamab with durvalumab, carboplatin and etoposide versus standard treatment in patients with previously untreated extensive stage small cell lung cancer

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 focuses on treating extensive stage small-cell lung cancer (ES-SCLC), an aggressive form of lung cancer that affects 10-15% of lung cancer patients and is commonly linked to smoking. The disease typically spreads quickly throughout the body, with about 70% of patients being diagnosed at an advanced stage when the cancer has already spread to other parts of the body.

The study will test a new treatment combination that includes tarlatamab, durvalumab, carboplatin, and etoposide, comparing it to a combination of durvalumab, carboplatin, and etoposide without tarlatamab. The purpose is to determine if adding tarlatamab to the standard treatment helps patients live longer. All medications will be given through an intravenous infusion, which means they are administered directly into a vein.

During the study, patients will be randomly assigned to receive either the new combination treatment or the standard treatment. The study will monitor how well patients respond to the treatment and track any side effects that may occur. The research team will continue to follow participants for several years to understand the long-term effects of the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive treatment through intravenous infusions that combine several medications:

    Group 1: tarlatamab, durvalumab, carboplatin, and etoposide

    Group 2: durvalumab, carboplatin, and etoposide

    The treatment group will be randomly assigned

  2. Step 2

    Regular health assessments

    Your doctor will monitor your health status regularly through:

    Blood tests to check organ function and blood cell counts

    Heart function tests including echocardiogram to measure heart pumping efficiency

    Imaging scans to measure how the cancer responds to treatment

  3. Step 3

    Treatment monitoring

    Regular checks of:

    Blood cell counts including neutrophils, platelets, and hemoglobin levels

    Liver and kidney function

    Heart function with minimum required pumping efficiency of 50%

    Any side effects that may occur during treatment

  4. Step 4

    Long-term follow-up

    The study continues until 2029

    Regular assessments of how long the treatment remains effective

    Monitoring of overall health status and survival

    Checks for any long-term effects of the treatment

Who can join the trial?

14 criteria

  • You must sign an informed consent form before any study procedures begin
  • You must be at least 18 years old or meet the legal age requirement in your country if it's higher
  • You must have been diagnosed with extensive-stage small-cell lung cancer confirmed by tissue or cell examination
  • Your cancer must be measurable using standard imaging techniques
  • You must not have received any previous treatment for small-cell lung cancer. If you had earlier treatment for limited-stage disease, at least 6 months must have passed since completion of treatment
  • Your doctor must determine that you are suitable to receive the study medications (carboplatin, etoposide, and durvalumab)
  • Your physical ability status must be good enough to carry out light activities (ECOG score of 0 or 1)
  • Your life expectancy must be at least 12 weeks
  • You must have adequate:
    • Blood cell counts within acceptable ranges
    • Blood clotting function within normal limits
    • Kidney function showing good filtration rate
    • Liver function with acceptable enzyme levels
    • Lung function without need for oxygen support
    • Heart function with ejection fraction of at least 50% and no significant heart problems

Who cannot join the trial?

14 criteria

  • History of other cancers in the past 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer)
  • Known active brain metastases (cancer that has spread to the brain) or spinal cord compression
  • Previous treatment with any cancer therapy for small cell lung cancer
  • Active or untreated infections, including tuberculosis or hepatitis B/C
  • Significant heart conditions, including:
    • Heart failure with symptoms
    • Unstable heart rhythm problems
    • Heart attack within the last 6 months
    • Severe lung disease that requires oxygen therapy
    • Active autoimmune diseases (conditions where the immune system attacks healthy cells)
    • Any condition that could interfere with the interpretation of study results
    • Known allergies to any of the study medications
    • Pregnant or breastfeeding women
    • Unable to swallow oral medications
    • Current participation in other clinical trials
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Investigated drugs

  • Tarlatamab

    is an investigational medication being studied for treating small-cell lung cancer. It is a new type of targeted therapy designed to fight cancer cells.

  • Durvalumab

    is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking certain proteins that cancer cells use to hide from the immune system.

  • Carboplatin

    is a chemotherapy medication that works by interfering with cancer cell growth and division. It is commonly used to treat various types of cancer, including lung cancer.

  • Etoposide

    is also a chemotherapy medication that works by stopping cancer cells from growing and dividing. It is often used in combination with other cancer treatments, particularly in treating lung cancer.

What is already known about the treatment

  • Tarlatamab

    An investigational bispecific antibody being studied in clinical trials for extensive stage small cell lung cancer (ES-SCLC). It is administered intravenously in combination with durvalumab, carboplatin, and etoposide as a first-line treatment. The medication is currently undergoing Phase 3 clinical trials to evaluate its efficacy in improving overall survival rates in patients with ES-SCLC.

  • Durvalumab

    An immunotherapy medication administered intravenously that works by blocking the PD-L1 protein, helping the immune system recognize and attack cancer cells. It is being studied in combination with other medications for the treatment of extensive stage small cell lung cancer, and has shown promising results in clinical trials as part of combination therapy.

  • Carboplatin

    A platinum-based chemotherapy drug administered intravenously that works by interfering with DNA replication in cancer cells, preventing them from dividing and growing. It is commonly used in combination therapy for various types of cancer, including small cell lung cancer, and has an established track record in cancer treatment protocols.

  • Etoposide

    A chemotherapy medication administered intravenously that works by blocking an enzyme needed for DNA repair, leading to cancer cell death. It is frequently used in combination with other medications for treating small cell lung cancer and has been a standard component of SCLC treatment regimens for many years.

Investigated diseases

Small-cell lung cancer - An aggressive type of lung cancer that develops from neuroendocrine cells in the lungs. It is strongly linked to smoking and represents 10-15% of all lung cancer cases. The disease is characterized by rapid growth and quick spread throughout the body. In extensive stage small-cell lung cancer, the cancer has already spread beyond the original location to distant parts of the body or is too large in size. This form of cancer grows much faster than many other types of lung cancer, with tumor cells multiplying rapidly. The extensive stage of this disease is the most common presentation, occurring in about 70% of patients at the time of diagnosis.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520050-38-00Protocol code20240178Estimated enrolment358 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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