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A study to evaluate the effectiveness of tarlatamab in patients with extensive-stage small cell lung cancer that has progressed after prior treatment and who have limited health status

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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 individuals diagnosed with extensive-stage small cell lung cancer, which is a type of lung cancer that has spread to other parts of the body. The research specifically looks at patients whose cancer has continued to grow even after receiving previous treatments, such as platinum-etoposide chemotherapy combined with an immune-checkpoint inhibitor. Additionally, the study involves participants with an ECOG performance status of 2, a scale used by doctors to describe how much a person's disease affects their daily activities and physical strength.

The purpose of this study is to evaluate the effectiveness of a drug called tarlatamab. This medication is an intravenous infusion, meaning it is delivered directly into a vein through a liquid solution. Participants in the trial will receive this treatment to see how it influences how long patients live and how the cancer responds to the medicine.

The research process

The trial runs in 1 step.

  1. Step 1

    Administration of tarlatamab

    The treatment involves receiving tarlatamab, which is an intravenous infusion. this means the medication is delivered directly into a vein through a tube.

    The dosage for this intravenous infusion is 10 mg (milligrams).

Who can join the trial?

9 criteria

  • You must have a confirmed diagnosis of extensive-stage small cell lung cancer, which is a type of lung cancer that has spread widely throughout the lungs or to other parts of the body.
  • You must have had a diagnosis confirmed through histology or cytology, which means a doctor has looked at your cells under a microscope to identify the cancer.
  • You must have previously received exactly one course of a specific treatment called platinum-etoposide doublet chemotherapy combined with an immune-checkpoint inhibitor (a type of medicine that helps your immune system fight cancer).
  • Your cancer must have progressed, meaning the cancer has grown or spread further despite the first treatment you received.
  • You must have an ECOG Performance Status of 2, which is a scale used by doctors to measure how much your cancer affects your daily activities; a score of 2 means you are capable of limited self-care and are able to carry out some light work or activities.
  • You must be 18 years of age or older.
  • You must have adequate organ function, meaning your vital organs like your liver, kidneys, and heart are working well enough to participate safely.
  • Female participants who are able to become pregnant must have a negative pregnancy test.
  • You must provide written informed consent, which means you have read and signed a document agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

8 criteria

  • Having cancer that has spread to the central nervous system, which is the part of the body consisting of the brain and spinal cord, and causing symptoms.
  • Having cancer that has spread to the leptomeninges, which are the protective layers covering the brain and spinal cord, or having pressure on the spinal cord.
  • A history of pneumonitis, which is inflammation of the lung tissue, caused by the immune system, that is moderate or severe, or having other serious side effects caused by the immune system.
  • Having interstitial lung disease, which is a group of conditions that cause scarring or inflammation in the lungs, or having active lung inflammation that is not caused by an infection.
  • Having an active autoimmune disease, which is a condition where the body's immune system mistakenly attacks its own healthy cells.
  • A history of having a solid organ transplant, which is when a healthy organ from one person is placed into another person.
  • Having or having had a viral infection that is not under control.
  • Having had a different type of malignancy, which is another word for cancer, within the last 2 years.
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Investigated drugs

Tarlatamab is a type of treatment that works by helping the body's own immune system find and attack specific cancer cells. It is given through an IV infusion into a vein.

What is already known about the treatment

Tarlatamab - This medication is an injectable solution or powder that is administered directly into a vein through an infusion. Currently being studied in clinical trials, it is used to treat patients with advanced small cell lung cancer that has not responded to previous treatments. It belongs to a class of drugs called T-cell engagers, which work by acting like a bridge to bring the body's immune cells directly to the cancer cells to destroy them.

Investigated diseases

Extensive-stage small cell lung cancer - This is a type of lung cancer that begins in the cells that line the airways. It is characterized by rapid growth and a tendency to spread quickly to other parts of the body, such as the lymph nodes or distant organs. In the extensive stage, the cancer has spread beyond the lung where it first started. As the disease progresses, tumor cells multiply and move throughout the chest and other systems. This rapid advancement typically requires management that addresses both the primary tumor and any secondary sites.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522288-13-00Protocol codeETOP29-25 START-lungEstimated enrolment50 patientsSponsorETOP IBCSG Partners Foundation

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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