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Testing Tarlatamab in Patients with Advanced Small-Cell Lung Cancer Who Have Poor Physical Condition

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with small-cell lung cancer that has spread to other parts of the body, which is called extensive stage disease. The study is specifically for patients who have a poor performance status, meaning they have significant limitations in their daily activities due to their illness. The treatment being tested is Tarlatamab, also known by its code name AMG 757, which is given as an infusion into a vein. This medication is a powder that is mixed with liquid before being given through an intravenous infusion. Patients enrolled in this study must have already received at least one previous treatment for their cancer that included platinum chemotherapy, etoposide, and an antibody treatment called a PD-L1 antibody.

The purpose of this study is to evaluate how well Tarlatamab works in treating patients with extensive stage small-cell lung cancer who have poor performance status and to see if this treatment is practical and manageable for these patients. The study will look at how many patients are alive after twelve months of treatment, which is the main focus of the research. It will also examine how long patients live overall, how long they live without their cancer getting worse, how many patients experience shrinkage of their tumors, and how many patients can tolerate the treatment until their first disease check-up.

During the study, patients will receive Tarlatamab treatment over a period of up to twelve months. The doctors will monitor how well the treatment works by checking if tumors shrink or disappear, including tumors that may have spread to the brain. They will also carefully watch for any side effects and assess the safety of the treatment. Additionally, the study will measure how the treatment affects patients' quality of life and their ability to perform daily activities. The research will also track how long it takes before patients need to start a different type of cancer treatment.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment initiation

    Upon joining the study, you will begin treatment with tarlatamab, which is a medication given through a vein in your arm (intravenous infusion).

    The medication comes as a powder that will be mixed into a solution before being given to you through an infusion.

  2. Step 2

    Regular treatment administration

    You will receive tarlatamab infusions at scheduled intervals throughout the study period.

    Each infusion will be administered directly into your bloodstream through a vein.

  3. Step 3

    First disease assessment

    After starting treatment, your disease will be evaluated to determine how the cancer is responding to the medication.

    This assessment will check whether the tumors have grown, shrunk, or remained stable.

  4. Step 4

    Ongoing monitoring and assessments

    Throughout the study, you will undergo regular evaluations to measure the effectiveness of the treatment.

    These assessments will track progression-free survival, which measures the length of time during and after treatment that the disease does not worsen.

    Your doctors will also monitor your overall survival, which is the length of time you remain alive after starting treatment.

    Special attention will be given to checking if the cancer in your brain (if present) responds to treatment through intracranial response assessments.

  5. Step 5

    Safety monitoring

    Your health will be closely monitored throughout the study to identify any side effects or complications from the treatment.

    This monitoring will assess the safety and tolerability of tarlatamab to ensure the medication is appropriate for you.

  6. Step 6

    Quality of life assessments

    You will be asked to complete questionnaires about your quality of life and any symptoms you experience.

    These questionnaires, called EORTC-QLQ-C30 and PRO CTCAE, help your doctors understand how the treatment affects your daily activities and well-being.

    The information you provide will help evaluate how the treatment impacts your overall quality of life.

  7. Step 7

    Continued treatment until progression or intolerance

    You will continue receiving tarlatamab infusions as long as the treatment is working and you are tolerating it well.

    Treatment will continue until your disease progresses, side effects become unmanageable, or you and your doctor decide to stop for another reason.

  8. Step 8

    Long-term follow-up

    After completing or stopping treatment, you will be followed for up to 12 months to assess your overall survival rate.

    Your doctors will also track the time to next-line systemic therapy, which measures how long it takes before you need to start a different cancer treatment.

    The study is expected to continue until January 2030 to gather complete information about the long-term effects of the treatment.

Who can join the trial?

8 criteria

  • You must sign a written consent form, which means you agree to participate in the study after understanding what it involves, before any study procedures begin
  • You must be 18 years of age or older
  • You must have an ECOG performance status of 2, which is a scale that measures how well you can perform daily activities, where 2 means you are able to care for yourself but cannot do work activities and are out of bed more than half the day
  • You must have small-cell lung cancer that has been confirmed by examining tissue under a microscope, which is called a biopsy. If your initial diagnosis showed mixed types of lung cancer, you may still qualify if a new biopsy of your current cancer shows small-cell lung cancer
  • Your cancer must have come back after treatment or spread to other parts of your body, which is called metastatic disease. If your cancer has only come back in one area, doctors must confirm that local treatment options like surgery or radiation are not suitable for you
  • You must have already received at least one treatment for your cancer after it came back or spread
  • You must have previously been treated with a combination that included platinum, which is a type of chemotherapy drug, etoposide, which is another chemotherapy drug, and a PD-L1 antibody, which is a type of immunotherapy that helps your immune system fight cancer. If you received only chemotherapy because immunotherapy was not safe for you due to other health reasons, you may still qualify
  • Your cancer must be measurable, which means doctors can see and measure your tumors on scans using specific guidelines called RECIST v1.1

Who cannot join the trial?

3 criteria

  • No specific exclusion criteria (reasons why you cannot join the study) have been provided in the available information for this clinical trial
  • You should discuss with the study doctor whether you are suitable to participate, as there may be additional requirements not listed in the basic study information
  • The study is designed for patients with extensive stage small-cell lung cancer (a type of lung cancer that has spread beyond one lung) who have poor performance status (meaning you have difficulty doing daily activities due to your illness)
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Investigated drugs

Tarlatamab is a medication being tested for the treatment of extensive stage small-cell lung cancer. It is designed to help fight cancer cells in patients whose cancer has spread beyond the lungs and who have a poor general health condition. This medicine works by helping the body's immune system recognize and attack cancer cells.

What is already known about the treatment

Tarlatamab – Tarlatamab is an investigational cancer medication given through an intravenous infusion (directly into a vein) that is currently being studied in clinical trials for the treatment of extensive stage small-cell lung cancer, particularly in patients with poor overall health status. This drug works by acting as a bispecific antibody that connects two different targets: it binds to both cancer cells (by recognizing a protein called DLL3 found on small-cell lung cancer cells) and immune system cells (specifically T-cells), bringing them together so the immune cells can attack and destroy the cancer cells. It belongs to a class of medications called bispecific T-cell engagers, which represent a newer approach to cancer treatment by harnessing the body's own immune system to fight tumors.

Investigated diseases

Small-Cell Lung Cancer – Small-cell lung cancer is a type of lung cancer that develops from cells in the airways of the lungs. It is called "small-cell" because the cancer cells appear small and round when viewed under a microscope. This cancer grows and spreads more quickly than other types of lung cancer. The disease often begins in the bronchi, which are the large airways in the center of the chest. As it progresses, the cancer can spread to other parts of the lungs and to distant organs in the body. Extensive stage small-cell lung cancer means the cancer has spread beyond one lung and nearby lymph nodes to other areas of the chest or body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522437-65-00Protocol codeAIO-TRK-0624Estimated enrolment57 patientsSponsorAIO-Studien gGmbH

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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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).