Study of Tarlatamab Treatment for Patients with Small Cell Lung Cancer Who Have Not Responded to Two or More Previous Treatments

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What is this study about?

This study focuses on Small Cell Lung Cancer (SCLC) that has returned or stopped responding to previous treatments. The research evaluates a new medication called tarlatamab (also known as AMG 757) in patients who have already undergone at least two different treatments, including one that contained platinum-based therapy. The purpose is to assess how well tarlatamab works and how safe it is for treating this type of lung cancer.

The treatment involves receiving intravenous infusions of tarlatamab, which is given as a powder that is mixed into a solution before administration. The study consists of three parts, with different doses of the medication being tested. During treatment, doctors will monitor how the cancer responds to the medication and track any side effects that may occur.

Patients may continue receiving the treatment for up to 24 months, as long as their cancer does not worsen and they do not experience unacceptable side effects. Throughout the study, doctors will perform regular assessments to measure how well the treatment is working, including checking if tumors have shrunk or disappeared, how long any improvements last, and how long patients survive without their cancer getting worse.

1 Initial assessment

Your doctor will perform measurements of your measurable lesions within 21 days before starting the treatment

Medical tests will check your blood counts, liver function, kidney function, heart function, and lung function to ensure you can safely participate

2 Treatment preparation

A tumor tissue sample will be required – either from previous procedures or through a new biopsy

If you have treated brain metastases, they must be stable and symptom-free for at least 7 days before starting treatment

3 Treatment administration

Tarlatamab will be given through an intravenous infusion (directly into your vein)

The medication comes as a powder that will be prepared as a solution for your infusion

Your treatment will continue until October 2025 or earlier if specified by your doctor

4 Monitoring during treatment

Regular assessments will track how your cancer responds to treatment

Your doctor will monitor for any side effects

Blood samples will be taken to measure drug levels and check for antibodies against the medication

Imaging scans will be performed to evaluate your response to treatment

5 Response evaluation

Your response to treatment will be assessed using specific criteria called RECIST 1.1

The evaluation will look for complete response (total disappearance of cancer), partial response (shrinkage of cancer), or disease control

The length of time your cancer responds to treatment will be measured

Who Can Join the Study?

Must be at least 18 years old
Must provide informed consent before any study procedures begin
Must have confirmed small cell lung cancer that has returned or not responded to previous treatments
Must have previously received treatment with platinum-based chemotherapy and at least one other therapy type
Must have adequate organ function including:
- Healthy blood cell counts
- Normal blood clotting function
- Adequate kidney function
- Sufficient liver function
- Normal breathing capacity
- Heart function with ejection fraction of at least 50%
Must be willing to provide a tumor tissue sample or undergo a tumor biopsy if needed
Must have a good physical condition (ECOG performance status of 0 or 1, meaning able to perform daily activities with minimal assistance)
Must have a life expectancy of at least 12 weeks
Must have measurable tumors that can be evaluated by imaging
If brain metastases (spread of cancer to brain) are present, they must be:
- Previously treated and stable
- Not causing symptoms for at least 7 days
- Not requiring steroid treatment (except for standard maintenance doses)

Who Cannot Join the Study?

Prior history of central nervous system metastases (cancer that has spread to the brain or spinal cord), unless treated and stable for at least 2 months
History of another type of cancer in the past 2 years, except for adequately treated non-melanoma skin cancer or cervical cancer in situ
Current participation in other clinical trials or treatment with investigational drugs within 28 days before starting this study
Significant heart conditions including:
- Uncontrolled high blood pressure
- Heart attack within the past 6 months
- Unstable heart rhythm problems
Active or chronic infections including hepatitis B, hepatitis C, or HIV
Severe liver problems or abnormal liver function tests
Severe kidney problems or significantly reduced kidney function
Any condition that, in the investigator’s opinion, would interfere with the patient’s ability to participate safely in the study
Pregnancy or breastfeeding
Unable or unwilling to use effective contraception during the study period

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Euromedica General Clinic Of Thessaloniki	Thessaloniki	Greece
University General Hospital Of Heraklion	Heraklion	Greece
Universitaetsklinikum Krems	Krems An Der Donau	Austria
Henry Dunant Hospital Center	Athens	Greece
Rigshospitalet	Copenhagen	Denmark
Centre Hospitalier Lyon Sud	Pierre Benite	France
Apzryri Ooxkhlghqzm Uzbwgbptmvicd Pvgtd	Parma	Italy
Itetwx Ivajpiug Fgnxzimpdrrja Oxaqpnpstba	Rome	Italy
Utmkouxfio Hbpqixqi Ctjpdzb	Cologne	Germany
Albqwwxfca Posflght Hmdlrnad Dk Mbvwgnttp	Marseille	France
Unqyomjbvyjgsaeuoqeyj Wjqilbbya Amh	Wuerzburg	Germany
Ugpqlqxxsvbabn Cgprtnm Kilzuxtwv	Gdansk	Poland
Haravdwz Du La Shfxs Ctxl I Sxzq Pzy	Barcelona	Spain
Hfqosrrc Vrrv dpqrmlxq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.10.2021
Belgium	Not recruiting	01.10.2021
Denmark	Not recruiting	01.10.2021
France	Not recruiting	01.10.2021
Germany	Not recruiting	01.10.2021
Greece	Not recruiting	01.10.2021
Italy	Not recruiting	01.10.2021
Poland	Not recruiting	01.10.2021
Spain	Not recruiting	01.10.2021

Trial locations

Investigated drugs:

Tarlatamab is an investigational medication being studied for the treatment of small cell lung cancer in patients who have already tried at least two other treatments that didn’t work well enough. It’s a new type of therapy that works by targeting specific proteins found on cancer cells. The medication is designed to help the body’s immune system recognize and fight cancer cells. The drug is administered to patients to evaluate how well it works in treating their cancer, how safe it is to use, and how the body processes it.

Small Cell Lung Cancer – A fast-growing type of lung cancer that typically starts in the bronchi (airways) of the lungs. The cancer cells are small and oval-shaped when viewed under a microscope, which gives this type of cancer its name. It tends to spread rapidly through the bloodstream and lymphatic system to other parts of the body. The disease often develops in the central part of the lungs and can create large tumors that grow quickly. Small cell lung cancer usually occurs in clusters of cancer cells, which can cause hormonal syndromes.

Trial ID:

2024-511837-37-00

Protocol code:

20200491

NCT ID:

NCT05060016

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tarlatamab Treatment for Patients with Small Cell Lung Cancer Who Have Not Responded to Two or More Previous Treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?