Study of Tarlatamab Treatment in Patients with Small Cell Lung Cancer: Evaluation of Different Dosing Schedules

2 1 1 1

What is this study about?

This study focuses on patients with Small Cell Lung Cancer (SCLC), an aggressive form of lung cancer. The research evaluates a medication called tarlatamab (also known as AMG 757), which is given through an intravenous infusion. The medication is provided as a powder that is mixed into a solution before administration into a vein.

The purpose of this research is to test different dosing schedules of tarlatamab to determine how well it works in treating Small Cell Lung Cancer. The study will include patients whose cancer has continued to grow or has returned after receiving previous treatment with platinum-based chemotherapy. Some patients may have also received prior treatment with other cancer medications.

During the study, participants will receive tarlatamab through regular intravenous infusions. Another medication called siltuximab may also be used as part of the treatment plan. Patients will have regular check-ups and tests to monitor their health and how their cancer responds to the treatment. The study team will track various aspects of the treatment’s effectiveness, including how the cancer responds and how long these responses last.

1 Initial screening and eligibility

Your eligibility for the study will be evaluated based on specific medical criteria, including confirmation of small cell lung cancer (SCLC) and previous treatment history

Medical tests will be performed to check your organ function and overall health status

A physical examination will assess your performance status using the ECOG scale (a measure of daily living abilities)

Imaging scans will be conducted to measure your cancer

2 Treatment assignment

You will be randomly assigned to receive tarlatamab through intravenous infusion

The medication will be given as a powder that is mixed into a solution for infusion

Treatment will be administered at the study center through your vein

3 Regular assessments

Your response to treatment will be monitored through regular imaging scans

Blood samples will be collected to measure tarlatamab levels in your body

Regular health checks will track any side effects

Your cancer’s response to treatment will be evaluated using standardized criteria

4 Follow-up period

Your health status will continue to be monitored after treatment completion

Regular check-ups will assess your long-term response to the treatment

The total study duration is expected to continue until May 29, 2029

Who Can Join the Study?

  • You must be at least 18 years old to participate
  • You must provide informed consent (written agreement to participate) before any study procedures begin
  • You must have Small Cell Lung Cancer (SCLC) confirmed by tissue or cell examination
  • Your cancer must have grown or returned after receiving platinum-based chemotherapy (a specific type of cancer treatment)
  • You must have measurable tumors that can be seen on scans within 21 days before starting the study
  • Your physical ability level must be good enough to carry out light activities (ECOG score of 0 or 1)
  • Your doctor must expect you to live for at least 12 weeks
  • Your major organs (blood, kidneys, liver, lungs, and heart) must be working well enough based on medical tests
  • Both men and women may participate in this study

Who Cannot Join the Study?

  • Previous participation in clinical trials involving tarlatamab treatment
  • History of severe allergic reactions to medications or biological products
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Significant heart conditions, including uncontrolled high blood pressure or recent heart attack
  • Active infections requiring systemic treatment (medications that affect the whole body)
  • Other active cancers requiring treatment (except for certain skin cancers or early-stage cancers)
  • Severe liver problems, indicated by abnormal liver function tests
  • Severe kidney problems, shown by reduced kidney function tests
  • Any condition that, in the doctor’s opinion, could make participation unsafe
  • Inability to understand or sign the informed consent form
  • Pregnancy or breastfeeding
  • Unwillingness to use effective birth control methods during the study
  • Major surgery within 4 weeks before starting the study
  • Use of other investigational drugs within 4 weeks before starting the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Foch Suresnes France
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario 12 De Octubre Madrid Spain
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Grand Hopital De Charleroi Charleroi Belgium
University General Hospital Of Heraklion Heraklion Greece
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Henry Dunant Hospital Center Athens Greece
Alexandra Hospital Athens Greece
Saarland University Hospital Homburg Germany
Jessa Ziekenhuis Hasselt Belgium
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Metropolitan Hospital Athens Greece
Abpmbcl Onwgrllemoq S Gdsgzvvw Atklojjfet Rome Italy
Adytao Mqcznnz Cggspr Sdpp Thessaloniki Greece
Uvomekqimseycwleosjqe Wjqujessh Azo Wuerzburg Germany
Uxguipgkhp Oh Adkgwgu Edegem Belgium
Hrehjvmo Vqxo deybbjmv Barcelona Spain
Hhocqyuc Uktxlwgyuguwm dx A Cabagn A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.04.2025
France France
Not recruiting
15.04.2025
Germany Germany
Not recruiting
15.04.2025
Greece Greece
Not recruiting
15.04.2025
Italy Italy
Not recruiting
15.04.2025
Spain Spain
Not recruiting
15.04.2025

Trial locations

Investigated drugs:

Tarlatamab is an investigational medication being studied for the treatment of small cell lung cancer (SCLC). It is a type of targeted therapy that works by binding to specific proteins on cancer cells. This medication is being tested to see how well it can help patients with SCLC by measuring how their tumors respond to the treatment. The medication is administered through intravenous infusion, which means it is given directly into the bloodstream through a vein.

Investigated diseases:

Small Cell Lung Cancer (SCLC) – A fast-growing type of lung cancer that develops in the lung’s smaller cells. It typically starts in the bronchi, which are the airways in the center of the chest, and can spread quickly to other parts of the body. The cancer cells are small and oval-shaped when examined under a microscope, which gives the disease its name. SCLC usually develops in people with a history of smoking and tends to grow and spread faster than non-small cell lung cancer. The disease often begins in the chest area and can cause symptoms such as coughing, chest pain, and shortness of breath.

Trial ID:
2024-516051-40-00
Protocol code:
20240092
NCT ID:
NCT06745323
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • 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

    Recruiting

    2 1 1
    Investigated drugs:
    France Greece Italy Spain
  • A study to investigate the safety and effects of ceralasertib, tremelimumab, and durvalumab in adults with various solid tumors

    Recruiting

    1 1 1 1
    Poland