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Study of Tarlatamab and Durvalumab compared to Durvalumab alone for patients with 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 study focuses on treating Extensive stage small cell lung cancer, a type of lung cancer that has spread to other parts of the body. The purpose of the study is to compare the effectiveness of using tarlatamab combined with durvalumab against using durvalumab alone. Participants may also receive other medications used for support, such as carboplatin, cisplatin, etoposide, dexamethasone, mannitol, argipressin, mycophenolate mofetil, infliximab, siltuximab, tocilizumab, paracetamol, or prednisolone.

The study is designed to see which treatment approach helps patients live longer, which is referred to as overall survival. Other factors being looked at include progression-free survival, which is the length of time during and after treatment that a disease does not get worse, and the time it takes for a disease to begin growing again. The study also monitors how the body responds to the medicine and any changes in symptoms like cough, chest pain, or dyspnea, which is the medical term for shortness of breath.

During the trial, participants are assigned to different groups to receive either the combination of medicines or a single medicine. Researchers will track how the drugs affect the body and any adverse events, which are unexpected or unpleasant side effects that occur during treatment. The study will also examine the amount of medicine present in the blood and how the body's health and quality of life change over time.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry and group assignment

    After joining the study, a randomization process occurs. this means a method is used to assign you to one of two different treatment groups by chance.

    One group will receive a combination of tarlatamab and durvalumab. tarlatamab is an experimental medicine delivered through an intravenous infusion (a liquid medicine passed into a vein).

    The other group will receive durvalumab alone via intravenous infusion.

  2. Step 2

    Treatment administration

    The primary medications are administered through intravenous use, which means the medicine is delivered directly into a vein.

    If assigned to the combination group, tarlatamab is administered as a powder for solution for infusion via intravenous use.

    durvalumab is also administered through intravenous use.

  3. Step 3

    Background medications

    During the trial, various background medications may be used to manage health conditions or side effects. these include electrolytes (such as mannitol) given through intravenous use to maintain fluid balance.

    Other medications that may be used include vasopressin, prednisolone, mycophenolate mofetil, and paracetamol, which are taken by oral use (swallowed by mouth).

    Additional medicines like infliximab, tocilizumab, etoposide, dexamethasone, siltuximab, carboplatin, and cisplatin may also be administered through intravenous use as part of the clinical care.

Who can join the trial?

9 criteria

  • The person must agree to participate in the study by signing an informed consent form, which is a document explaining the study details before any tests begin.
  • The person must be at least 18 years old or the legal age in their country.
  • The person must have extensive stage small cell lung cancer, which is a type of lung cancer that has spread beyond the lung where it first started.
  • The person must have finished 4 cycles of platinum-etoposide chemotherapy (a specific type of cancer treatment using drugs) along with durvalumab (an immunotherapy drug) as their first treatment.
  • The cancer must not have gotten worse during the initial treatment; it must be stable (not growing) or showing a response (getting smaller or disappearing).
  • The person must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well a patient can perform daily activities and how much their cancer affects their lifestyle.
  • The person must be expected to live for more than 12 weeks.
  • Any toxicities (harmful side effects) from previous radiation or chemotherapy must have improved to a grade 1 or lower, meaning the side effects are very mild, though hair loss or tiredness are allowed.
  • The person must have adequate organ function, meaning their vital organs like the heart, liver, and kidneys are working well enough to safely participate.

Who cannot join the trial?

26 criteria

  • People who have metastases, which means the cancer has spread, to the central nervous system (the brain and spinal cord) that causes symptoms, or leptomeningeal disease, which is when cancer spreads to the protective layers covering the brain and spinal cord.
  • People who have previously received a solid organ transplant, such as a kidney, heart, or liver from a donor.
  • People who have had a myocardial infarction (a heart attack) or congestive heart failure (a condition where the heart cannot pump blood well enough) that causes symptoms within 6 months before starting the study treatment.
  • People who have had major surgical procedures in the 6 months before starting the treatment.
  • People who have a history of arterial thrombosis, which is a blood clot in an artery, within 6 months before starting the treatment.
  • People who have previously used any medicine that targets the DLL3 pathway.
  • People who are currently receiving other anticancer therapies, although certain hormone treatments for breast cancer are allowed.
  • Men who are not willing to avoid donating sperm during the treatment period.
  • Women who are currently breastfeeding or plan to breastfeed during the study.
  • Women who are able to become pregnant but are unwilling to use the specific contraception (birth control) methods required by the study.
  • People with an active HIV infection or hepatitis (a disease that causes liver inflammation).
  • People with evidence of interstitial lung disease (ILD), which is scarring or inflammation of the lung tissue, or pneumonitis, which is inflammation of the lung tissue that is not caused by an infection.
  • Women who are able to become pregnant and have a positive pregnancy test during the screening process.
  • Men who have a female partner who is able to become pregnant and is unwilling to avoid sex or use contraception during the study.
  • People with a history of allergic reactions or hypersensitivity reactions (severe allergic responses) to antibody therapies, platinum chemotherapy, or etoposide.
  • People showing signs of an active systemic infection (an infection throughout the body) that requires antibiotics within 7 days before starting the treatment.
  • People who have received live vaccines within 4 weeks or inactive vaccines within 30 days before starting the treatment.
  • Women who plan to become pregnant or donate eggs while participating in the study.
  • People with any other clinically significant disorder, meaning any other medical condition that is important to the doctors.
  • People who have used systemic corticosteroids (strong anti-inflammatory medicines) or immunosuppressive therapy (medicines that lower the immune system) within 14 days before starting the treatment.
  • People who have received or plan to receive consolidative chest radiation for their cancer.
  • People who have had severe or life-threatening events caused by immune-mediated therapy (treatments that affect the immune system).
  • People who are participating in another investigational trial (a different clinical study).
  • People who have a known sensitivity (allergy) to any of the medicines or ingredients used in this study.
  • People who have had a different type of malignancy (cancer) within the last 2 years.
  • People with an active or past history of autoimmune or inflammatory disorders, which are conditions where the body's immune system attacks its own healthy cells.
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Investigated drugs

  • Tarlatamab

    is an investigational therapy used in this study to help the body's immune system find and attack certain cancer cells.

  • Durvalumab

    is a medication used in this study to help the immune system recognize and fight cancer cells.

What is already known about the treatment

  • Durvalumab

    This medication is administered through an intravenous infusion to treat certain types of cancer. It is currently an established treatment used to help the body's immune system recognize and attack cancer cells. As a type of immunotherapy, it works by blocking specific proteins on immune cells that prevent them from attacking tumors.

  • Tarlatamab

    This is an investigational medication administered as an intravenous infusion via a powder solution. It is currently being studied in clinical trials for the treatment of extensive stage small cell lung cancer. Classified as a T-cell engager, it works by physically linking immune cells directly to cancer cells to trigger a targeted attack.

Investigated diseases

Extensive stage small cell lung cancer - This is a type of lung cancer that starts in the cells that line the airways. In its extensive stage, the cancer has spread beyond the lung where it first began to other parts of the body. The disease often progresses rapidly as cancerous cells multiply and move through the bloodstream or lymphatic system. As it advances, it can affect various organs and systems throughout the body. Physical symptoms may include difficulty breathing, chest pain, and persistent coughing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505989-29-00Protocol code20200041Estimated enrolment558 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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