Study of tarlatamab with durvalumab, carboplatin and etoposide versus standard treatment in patients with previously untreated extensive stage small cell lung cancer

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What is this study about?

This clinical trial focuses on treating extensive stage small-cell lung cancer (ES-SCLC), an aggressive form of lung cancer that affects 10-15% of lung cancer patients and is commonly linked to smoking. The disease typically spreads quickly throughout the body, with about 70% of patients being diagnosed at an advanced stage when the cancer has already spread to other parts of the body.

The study will test a new treatment combination that includes tarlatamab, durvalumab, carboplatin, and etoposide, comparing it to a combination of durvalumab, carboplatin, and etoposide without tarlatamab. The purpose is to determine if adding tarlatamab to the standard treatment helps patients live longer. All medications will be given through an intravenous infusion, which means they are administered directly into a vein.

During the study, patients will be randomly assigned to receive either the new combination treatment or the standard treatment. The study will monitor how well patients respond to the treatment and track any side effects that may occur. The research team will continue to follow participants for several years to understand the long-term effects of the treatment.

1 Initial treatment phase

You will receive treatment through intravenous infusions that combine several medications:

Group 1: tarlatamab, durvalumab, carboplatin, and etoposide

Group 2: durvalumab, carboplatin, and etoposide

The treatment group will be randomly assigned

2 Regular health assessments

Your doctor will monitor your health status regularly through:

Blood tests to check organ function and blood cell counts

Heart function tests including echocardiogram to measure heart pumping efficiency

Imaging scans to measure how the cancer responds to treatment

3 Treatment monitoring

Regular checks of:

Blood cell counts including neutrophils, platelets, and hemoglobin levels

Liver and kidney function

Heart function with minimum required pumping efficiency of 50%

Any side effects that may occur during treatment

4 Long-term follow-up

The study continues until 2029

Regular assessments of how long the treatment remains effective

Monitoring of overall health status and survival

Checks for any long-term effects of the treatment

Who Can Join the Study?

  • You must sign an informed consent form before any study procedures begin
  • You must be at least 18 years old or meet the legal age requirement in your country if it’s higher
  • You must have been diagnosed with extensive-stage small-cell lung cancer confirmed by tissue or cell examination
  • Your cancer must be measurable using standard imaging techniques
  • You must not have received any previous treatment for small-cell lung cancer. If you had earlier treatment for limited-stage disease, at least 6 months must have passed since completion of treatment
  • Your doctor must determine that you are suitable to receive the study medications (carboplatin, etoposide, and durvalumab)
  • Your physical ability status must be good enough to carry out light activities (ECOG score of 0 or 1)
  • Your life expectancy must be at least 12 weeks
  • You must have adequate:
    • Blood cell counts within acceptable ranges
    • Blood clotting function within normal limits
    • Kidney function showing good filtration rate
    • Liver function with acceptable enzyme levels
    • Lung function without need for oxygen support
    • Heart function with ejection fraction of at least 50% and no significant heart problems

Who Cannot Join the Study?

  • History of other cancers in the past 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer)
  • Known active brain metastases (cancer that has spread to the brain) or spinal cord compression
  • Previous treatment with any cancer therapy for small cell lung cancer
  • Active or untreated infections, including tuberculosis or hepatitis B/C
  • Significant heart conditions, including:
    • Heart failure with symptoms
    • Unstable heart rhythm problems
    • Heart attack within the last 6 months
  • Severe lung disease that requires oxygen therapy
  • Active autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Any condition that could interfere with the interpretation of study results
  • Known allergies to any of the study medications
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Current participation in other clinical trials

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
Koranyi National Institute For Pulmonology Budapest Hungary
Centre Hospitalier Intercommunal Creteil Creteil France
Medical University Of Graz Graz Austria
University Hospital Maastricht Maastricht The Netherlands
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Centre Hospitalier Universitaire Rouen Rouen France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Centre hospitalier universitaire de Liege Liege Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Universitaetsklinikum Krems Krems An Der Donau Austria
Henry Dunant Hospital Center Athens Greece
Centrum Pulmonologii I Torakochirurgii W Bystrej Wilkowice Poland
HIA Sainte Anne Toulon France
Matrai Gyogyintezet Gyongyos Hungary
Institutul Regional De Oncologie Iasi Iasi Romania
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Hospital Da Luz S.A. Lisbon Portugal
Klinikum Chemnitz gGmbH Chemnitz Germany
Kliniken der Stadt Koeln gGmbH Cologne Germany
Jessa Ziekenhuis Hasselt Belgium
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital Cuf Tejo S.A. Lisbon Portugal
Cliniche Gavazzeni S.p.A. Bergamo Italy
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Cuyfia Lwfi Barsfw Lyon France
Uffgktyqsqyilhuhxtjjr Eqixk Adl Essen Germany
Uowooqfhlwfu Myvkryy Chvvdja Gumgsvlav Groningen The Netherlands
Auvndvi Oucflrawxes S Gbwsxgtx Aqlwwmybsg Rome Italy
Noignawq Itdgveypz Oz Tpxinkhxdoqf Ady Lgzb Djqwbvmy Warsaw Poland
Iseanfqy Rggvxdbhq Prg Lv Sluszc Dwn Thcism Dcet Adjbkgu Ievo Snqbli Meldola Italy
Amhisimlqc Psocnphe Hoybxewp Dm Mleotlzid Marseille France
Eulqrho Uoxuckezbtep Mdsvwxd Ctfglmv Rgwkoujbo (hdzupbu Mmy Rotterdam The Netherlands
Adopkn Mafbabp Covkae Sgkc Thessaloniki Greece
Ulmyznffywbsbcvaflkqx Wwzhgcorn Atw Wuerzburg Germany
Udjatguzxlsnjl Cyphpnv Kwjrblvnl Gdansk Poland
Hsfgfzcb Dp Lq Sdwsz Chys I Sofe Pty Barcelona Spain
Hcjpriyh Vcyn dzkftxhe Barcelona Spain
Iniiwiep Cpsym 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
20.10.2025
Belgium Belgium
Not recruiting
20.10.2025
Denmark Denmark
Not recruiting
20.10.2025
France France
Not recruiting
20.10.2025
Germany Germany
Not recruiting
20.10.2025
Greece Greece
Recruiting
20.10.2025
Hungary Hungary
Not recruiting
20.10.2025
Italy Italy
Not recruiting
20.10.2025
Poland Poland
Not recruiting
20.10.2025
Portugal Portugal
Not recruiting
20.10.2025
Romania Romania
Not recruiting
20.10.2025
Spain Spain
Not recruiting
20.10.2025
The Netherlands The Netherlands
Not recruiting
20.10.2025

Trial locations

Tarlatamab is an investigational medication being studied for treating small-cell lung cancer. It is a new type of targeted therapy designed to fight cancer cells.

Durvalumab is an immunotherapy medication that helps the body’s immune system fight cancer cells. It works by blocking certain proteins that cancer cells use to hide from the immune system.

Carboplatin is a chemotherapy medication that works by interfering with cancer cell growth and division. It is commonly used to treat various types of cancer, including lung cancer.

Etoposide is also a chemotherapy medication that works by stopping cancer cells from growing and dividing. It is often used in combination with other cancer treatments, particularly in treating lung cancer.

Small-cell lung cancer – An aggressive type of lung cancer that develops from neuroendocrine cells in the lungs. It is strongly linked to smoking and represents 10-15% of all lung cancer cases. The disease is characterized by rapid growth and quick spread throughout the body. In extensive stage small-cell lung cancer, the cancer has already spread beyond the original location to distant parts of the body or is too large in size. This form of cancer grows much faster than many other types of lung cancer, with tumor cells multiplying rapidly. The extensive stage of this disease is the most common presentation, occurring in about 70% of patients at the time of diagnosis.

Trial ID:
2024-520050-38-00
Protocol code:
20240178
Trial Phase:
Therapeutic confirmatory (Phase III)

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