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

Other Sites

Site Name City Country Status
Hospital Da Luz S.A. Lisbon Portugal
Az Maria Middelares Gent Gent Belgium
Universitaetsklinikum Krems Krems An Der Donau Austria
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Spitalul Municipal Ploiesti Ploiesti Romania
Azorg Aalst Belgium
Semmelweis University Budapest Hungary
CHU UCL Namur Yvoir Belgium
Cajirjsfd Udkvsndkyifyxs Syostfols Woluwe-Saint-Lambert Belgium
Ibnnoquy Jgtne Bgoafs Anderlecht Belgium
Hecgtfxy Vcgy dbshgavq Barcelona Spain
Bgjkgbqj Hakcqial Dublin Ireland
Fqdcramx nlmxpvgwx Milyi a Hsfqjtg Prague Czechia
Onexuf Ujumrshfuu Hftwnmoj Odense Denmark
Hxtvmrkc Ciqtfh Df Btvxcwzjr Barcelona Spain
Euzwsor Uvqeweokfkss Mwzywcn Ceuymtf Rarskcrun (jaqqjdu Mpv Rotterdam The Netherlands
Uudtmqxelctgpfhsocvns Mijqlzcj Aqb Munster Germany
Anbiex Mslyihu Cyafek Sodb Thessaloniki Greece
Tghdhbsiulkw Hcqkchehya gjzcu Heidelberg Germany
Rtxfyjxoqryshu Copenhagen Denmark
Ufcccbrwwgibml Chqotai Khsosygtg Gdansk Poland
Hywnbkbo Du La Scleh Crzq I Sckx Pqa Barcelona Spain
Czjdbq Lxqc Bvmhng Lyon France
Usmmupswoy Of Asfpvse Edegem Belgium
Uheakxkntnqfytxgadbsu Emkfj Amg Essen Germany
Ubknwkihmare Mtevkwz Cnhsjor Gzyqtncyr Groningen The Netherlands
Vsrks Ulsukozbyhae Blxduet Jette Belgium
Itnfjbdg Cixone Dwiwiqihrdjzerdqm L'hospitalet De Llobregat Spain
Iwloxziq Tuwiib Bgrr Gsidzeic Pgakz Ii Bari Italy
Cfwsbrj Ouakgoqwmvv Ctjrjg Pfxnptz Emee Plovdiv Bulgaria
Hjhomcdh Cub Pazsv Sxhm Porto Portugal
Ihucjtbp Rlfaudfk Dt Caprab Dz Myjvyvubhgn Montpellier France
Mlie Sjlttgy Lvxr Sofia Bulgaria
Lfm Hcnzfewa Uvxnxcejtgrkis Dv Smzlvtsuea STRASBOURG, Alsace France
Caudba Hxpzfoqnkva Eu Uoixhcjfyignn Dc Lvcsive Limoges France
Avsnycgljg Pysqnanh Hvijjpaj Dt Piyef Paris France
Cxbnsy Hpbbwlseztk Uclpoaaetweds Du Noziyt Saint-Herblain France
Amviq Hdlanjehkqvx Najy Acdihe Cjwtzlpx Valenciennes France
Veoxlehjunfc Kvryhkbqcsclyoqoexmoycayfcphbdbx miw Feldkirch Austria
Gttsjtcxkkxwjglcp Vqldcijcb Pmus Alaowi Efxucvan Oxawrv Kiktdb Gyor Hungary
Tvwckuacddvfyexmk Tsurtpplrdqvn Torokbalint Hungary
Wnrfcqwsslyve Cgrnjfn Pjyybcsuaofe I Tqncqmtsrkzgzfs Izs Ejjpesp I Jrzvpha Zbclfpdsh Poznan Poland
Zqelclkkcl Oeyh Lcfyukp Genk Belgium
Nbmbbxxjf Aieb Osdyhwxacugriwdye aopf Ostrava Czechia
Nhwdigoc Ipjmuljhf Oy Tqlpaatgvyeg Avm Ldqh Dvgztjtp Warsaw Poland
Dxpunzuqjoxu Cabznxu Oadcchlaf Pamqunjsygqt I Hxegzmkvghp Wroclaw Poland
Hxziknie Cnu Doenxircrcc Sepb Lisbon Portugal
Mxibfstxohtk Hphhcdgy Fgf Awykxd Tbbltrdjxoqqp Huztgeoi Lrjs Panagyurishte Bulgaria
Iqwzatbl Civio Paris France
Aomasrfabp Pplmdyrt Hwehuoot Du Mewuxamfq Marseille France
Cefzvv Hiazttwxxpy Lh Mont Le Mans France
Aaybougbcl Zobukcpqoh Msaqqyhhqz Maastricht The Netherlands
Kliljimf dmj Sxnym Kngfb gztaz Cologne Germany
Mobkzqvxlqou Hnaafjdv Athens Greece
Ctr Hyizsk Mons Belgium
Mjgcqmy Ungxzwynrv Oi Gfje Graz Austria
Ubymgritxyyhwzqffftlr Wvnuudnxr Abv Wuerzburg Germany

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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