Study of Tarlatamab and Durvalumab compared to Durvalumab alone for patients with extensive stage small cell lung cancer

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What is this study about?

This study focuses on treating Extensive stage small cell lung cancer, a type of lung cancer that has spread to other parts of the body. The purpose of the study is to compare the effectiveness of using tarlatamab combined with durvalumab against using durvalumab alone. Participants may also receive other medications used for support, such as carboplatin, cisplatin, etoposide, dexamethasone, mannitol, argipressin, mycophenolate mofetil, infliximab, siltuximab, tocilizumab, paracetamol, or prednisolone.

The study is designed to see which treatment approach helps patients live longer, which is referred to as overall survival. Other factors being looked at include progression-free survival, which is the length of time during and after treatment that a disease does not get worse, and the time it takes for a disease to begin growing again. The study also monitors how the body responds to the medicine and any changes in symptoms like cough, chest pain, or dyspnea, which is the medical term for shortness of breath.

During the trial, participants are assigned to different groups to receive either the combination of medicines or a single medicine. Researchers will track how the drugs affect the body and any adverse events, which are unexpected or unpleasant side effects that occur during treatment. The study will also examine the amount of medicine present in the blood and how the body’s health and quality of life change over time.

Who Can Join the Study?

  • The person must agree to participate in the study by signing an informed consent form, which is a document explaining the study details before any tests begin.
  • The person must be at least 18 years old or the legal age in their country.
  • The person must have extensive stage small cell lung cancer, which is a type of lung cancer that has spread beyond the lung where it first started.
  • The person must have finished 4 cycles of platinum-etoposide chemotherapy (a specific type of cancer treatment using drugs) along with durvalumab (an immunotherapy drug) as their first treatment.
  • The cancer must not have gotten worse during the initial treatment; it must be stable (not growing) or showing a response (getting smaller or disappearing).
  • The person must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well a patient can perform daily activities and how much their cancer affects their lifestyle.
  • The person must be expected to live for more than 12 weeks.
  • Any toxicities (harmful side effects) from previous radiation or chemotherapy must have improved to a grade 1 or lower, meaning the side effects are very mild, though hair loss or tiredness are allowed.
  • The person must have adequate organ function, meaning their vital organs like the heart, liver, and kidneys are working well enough to safely participate.

Who Cannot Join the Study?

  • People who have metastases, which means the cancer has spread, to the central nervous system (the brain and spinal cord) that causes symptoms, or leptomeningeal disease, which is when cancer spreads to the protective layers covering the brain and spinal cord.
  • People who have previously received a solid organ transplant, such as a kidney, heart, or liver from a donor.
  • People who have had a myocardial infarction (a heart attack) or congestive heart failure (a condition where the heart cannot pump blood well enough) that causes symptoms within 6 months before starting the study treatment.
  • People who have had major surgical procedures in the 6 months before starting the treatment.
  • People who have a history of arterial thrombosis, which is a blood clot in an artery, within 6 months before starting the treatment.
  • People who have previously used any medicine that targets the DLL3 pathway.
  • People who are currently receiving other anticancer therapies, although certain hormone treatments for breast cancer are allowed.
  • Men who are not willing to avoid donating sperm during the treatment period.
  • Women who are currently breastfeeding or plan to breastfeed during the study.
  • Women who are able to become pregnant but are unwilling to use the specific contraception (birth control) methods required by the study.
  • People with an active HIV infection or hepatitis (a disease that causes liver inflammation).
  • People with evidence of interstitial lung disease (ILD), which is scarring or inflammation of the lung tissue, or pneumonitis, which is inflammation of the lung tissue that is not caused by an infection.
  • Women who are able to become pregnant and have a positive pregnancy test during the screening process.
  • Men who have a female partner who is able to become pregnant and is unwilling to avoid sex or use contraception during the study.
  • People with a history of allergic reactions or hypersensitivity reactions (severe allergic responses) to antibody therapies, platinum chemotherapy, or etoposide.
  • People showing signs of an active systemic infection (an infection throughout the body) that requires antibiotics within 7 days before starting the treatment.
  • People who have received live vaccines within 4 weeks or inactive vaccines within 30 days before starting the treatment.
  • Women who plan to become pregnant or donate eggs while participating in the study.
  • People with any other clinically significant disorder, meaning any other medical condition that is important to the doctors.
  • People who have used systemic corticosteroids (strong anti-inflammatory medicines) or immunosuppressive therapy (medicines that lower the immune system) within 14 days before starting the treatment.
  • People who have received or plan to receive consolidative chest radiation for their cancer.
  • People who have had severe or life-threatening events caused by immune-mediated therapy (treatments that affect the immune system).
  • People who are participating in another investigational trial (a different clinical study).
  • People who have a known sensitivity (allergy) to any of the medicines or ingredients used in this study.
  • People who have had a different type of malignancy (cancer) within the last 2 years.
  • People with an active or past history of autoimmune or inflammatory disorders, which are conditions where the body’s immune system attacks its own healthy cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Centre Hospitalier Intercommunal Creteil Creteil France
Koranyi National Institute For Pulmonology Budapest Hungary
Medical University Of Graz Graz Austria
University Hospital Maastricht Maastricht The Netherlands
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Hospital Universitario De Navarra Pamplona Spain
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Az Maria Middelares Gent Gent Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Hospital Cuf Descobertas S.A. Lisbon Portugal
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Spitalul Municipal Ploiesti Ploiesti Romania
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Universitaetsklinikum Krems Krems An Der Donau Austria
Henry Dunant Hospital Center Athens Greece
MBAL Serdika Ltd. Sofia Bulgaria
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Nemocnice AGEL Ostrava-Vitkovice a.s. Ostrava Czechia
Matrai Gyogyintezet Gyongyos Hungary
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Odense University Hospital Odense Denmark
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Le Mans Le Mans France
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Brno Brno Czechia
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Feldkirch Austria
Semmelweis University Budapest Hungary
Kliniken der Stadt Koeln gGmbH Cologne Germany
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
St. Luke’s Hospital S.A. Thessaloniki Greece
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
University Hospital Olomouc Olomouc Czechia
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Ziekenhuis Oost Limburg Genk Belgium
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Rigshospitalet Copenhagen Denmark
CHU Helora La Louviere Belgium
Vrije Universiteit Brussel Jette Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Beaumont Hospital Dublin Ireland
Hospital CUF Porto S.A. Porto Portugal
Metropolitan Hospital Athens Greece
Cytxbygex Uztasbcmffhkvt Scyvsbhci Woluwe-Saint-Lambert Belgium
Iqwmrwsz Revmbiqb Dv Cnljqn Dd Mkqnukwlyvb Montpellier France
Crplgp Lhhf Bhoyqz Lyon France
Unhrpzjpyckhadnnlijlo Ejdlz Abi Essen Germany
Ujfcpufkajmp Mlipoxa Clqojsn Gklkqyvli Groningen The Netherlands
Ifozqdqr Cpvgix Dfjntgakhstkkunrp L'hospitalet De Llobregat Spain
Nxauutmy Iezspskjv Og Tnyuwffihmrn Avp Lldq Dkcfotwa Warsaw Poland
Dslvhxcgrehq Cixtzis Ovqjbshcy Puyayzsuchns I Hybolixnbfb Wroclaw Poland
Cmuplc Hiramcvlpcf Ec Uqheuedtgistt Dq Lceggvo Limoges France
Ayqetwmjfj Pwwisguv Hoczbeli Da Pxhnx Paris France
Axdtw Hgikltmqovrm Nkka Aqcrvp Ciafuxlf Valenciennes France
Fddizjmv nzazhaoqf Magbn a Hahryqi Prague Czechia
Atpmetsqwa Ppbohvkr Hgzykfac Dc Msfhjycma Marseille France
Ectdsnd Uzczcxcjmgbr Mgieemv Ctcebeq Razfdkkky (wmiuyrs Mxh Rotterdam The Netherlands
Uropaoikkxsmcuzzvwzuy Mdsnlriq Auw Munster Germany
Gkrejhgpedbbgzzdo Vsbxblwru Pfjt Asopxm Effyoppi Oewkbk Kjhlty Gyor Hungary
Avydja Mwufzcp Ctadyb Sswu Thessaloniki Greece
Uoaxgwvfksfecddelxhwt Wkmbuldrr Abi Wuerzburg Germany
Uqkrfrsddxzhas Cwburfa Kgdbahguv Gdansk Poland
Hjqawxks Dc Lz Srbio Cvyt I Smre Pyu Barcelona Spain
Upjkzizmbq On Afdgepb Edegem Belgium
Hwclmbnz Vyxd djxmtokf Barcelona Spain
Ifqfkwvi Ckpgh Paris France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
13.12.2024
Belgium Belgium
Not recruiting
13.12.2024
Bulgaria Bulgaria
Not recruiting
13.12.2024
Czechia Czechia
Not recruiting
13.12.2024
Denmark Denmark
Not recruiting
13.12.2024
France France
Not recruiting
13.12.2024
Germany Germany
Not recruiting
13.12.2024
Greece Greece
Not recruiting
13.12.2024
Hungary Hungary
Not recruiting
13.12.2024
Ireland Ireland
Not recruiting
13.12.2024
Italy Italy
Not recruiting
13.12.2024
Poland Poland
Not recruiting
13.12.2024
Portugal Portugal
Not recruiting
13.12.2024
Romania Romania
Not recruiting
13.12.2024
Spain Spain
Not recruiting
13.12.2024
The Netherlands The Netherlands
Not recruiting
13.12.2024

Trial locations

Tarlatamab is an investigational therapy used in this study to help the body’s immune system find and attack certain cancer cells.

Durvalumab is a medication used in this study to help the immune system recognize and fight cancer cells.

Extensive stage small cell lung cancer – This is a type of lung cancer that starts in the cells that line the airways. In its extensive stage, the cancer has spread beyond the lung where it first began to other parts of the body. The disease often progresses rapidly as cancerous cells multiply and move through the bloodstream or lymphatic system. As it advances, it can affect various organs and systems throughout the body. Physical symptoms may include difficulty breathing, chest pain, and persistent coughing.

Trial ID:
2023-505989-29-00
Protocol code:
20200041
NCT ID:
NCT06211036
Trial Phase:
Therapeutic confirmatory (Phase III)

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