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

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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 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.

The research process

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

Step 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
Step 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
Step 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
Step 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 trial?

9 criteria

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 trial?

14 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Alexandra Hospital
Verified
Athens, Greece
Athens Medical Center S.A.
Verified
Thessaloniki, Greece
Grand Hopital De Charleroi
Responsive
Charleroi, Belgium

Trial locations

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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.

What is already known about the treatment

Tarlatamab - An investigational bispecific antibody medication administered through intravenous infusion, currently being studied in clinical trials for the treatment of Small Cell Lung Cancer (SCLC). This novel therapeutic agent works by simultaneously targeting two different proteins: one on cancer cells and another on immune cells, helping to direct the body's immune system to attack cancer cells. As a targeted immunotherapy, tarlatamab represents a new approach in SCLC treatment, where it is being evaluated for its ability to achieve objective response rates in patients, as assessed through standardized tumor measurement criteria (RECIST 1.1) under blinded independent review.

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.