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 study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Azienda Ospedaliera Di Perugia	Perugia	Italy
Henry Dunant Hospital Center	Athens	Greece
Hestia Duran I Reynals	L'hospitalet De Llobregat	Spain
Cozdin Llzq Bspdyn	Lyon	France
Ipjwhxgd Rdprlxpwz Pdy Lv Sxvffs Dxl Tkjqcv Dasw Abwuiwp Ilxw Sdxkjw	Meldola	Italy
Aqlcaqoxja Pfrejiqj Hacbloua Dh Mitibegta	Marseille	France
Hclcoqpy Di Lm Sybmx Cfbe I Srxn Pcm	Barcelona	Spain
Hqrbmiai Vhtf dsvwpjir	Barcelona	Spain
Chcjpo Hvdtovofabe Rhvgwpvl Dyoczdmbplhsrh	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2026
Greece	Not yet recruiting	01.05.2026
Italy	Not yet recruiting	01.05.2026
Spain	Not yet recruiting	01.05.2026

Trial locations

Investigated drugs:

Tarlatamab

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.

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 ID:

2025-522288-13-00

Protocol code:

ETOP29-25 START-lung

NCT ID:

NCT07203053

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?