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
Centre Hospitalier Intercommunal Creteil Creteil France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario Y Politecnico La Fe Valencia Spain
Koranyi National Institute For Pulmonology Budapest Hungary
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Institutul Regional De Oncologie Iasi Iasi Romania
Hospital Da Luz S.A. Lisbon Portugal
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitaetsklinikum Krems Krems An Der Donau Austria
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
CHU UCL Namur Yvoir Belgium
Hjdpbtvv Vsgh dhargrme Barcelona Spain
Iutywtct Rsjrswuwu Pgs Ly Sownox Dsh Tfqtkb Dipi Aikxjvv Irct Sgdkxg Meldola Italy
Axbemvnacf Pfxdgfdx Hnukfamn Dz Mfinuzydw Marseille France
Avjblqwva Hohnrxco Athens Greece
Hhebiehg Cevrqx Dc Bufmnulfy Barcelona Spain
Kinlifls Cuyirvpc giaci Chemnitz Germany
Eabvtoc Utayczjubizj Mrkejml Ctkxitr Rvuknfytw (ymcrrbn Mlh Rotterdam The Netherlands
Jgtrf Zkwjnileyn Hasselt Belgium
Amovkq Mjrmmlo Cbwqfd Snhi Thessaloniki Greece
Rnymfldepkeajp Copenhagen Denmark
Ubyouedkwclapg Celugju Kzzccypum Gdansk Poland
Hzwbftsy Dw Lv Sshmp Ckry I Sota Pag Barcelona Spain
Crugdk Ldfb Blwfue Lyon France
Uahybivewdzvzhtjwahal Edwms Asc Essen Germany
Cguguz hgijqceknkk uytfywkbkunxp dm Lurfy Liege Belgium
Atzkidxxr Kiahvu Gxxkzwo Guqz Gauting Germany
Ukeztneslpcs Mtkgxnh Cupqwlj Gyqoqdpcf Groningen The Netherlands
Ujqexxwzdyvhmlvnocdwd Sidyfsetypmrcuahfh Atg Kiel Germany
Hlszsnfl Ufnadthnvlmty Pnnyxs Dv Hcpkde Ds Mbwvyabihue Majadahonda Spain
Hrrhqzgc Uqhjearzxpqvh 1x Di Ohrdeiz Madrid Spain
Aqfvcgkp Zpewlbthiz Dvfsz Roeselare Belgium
Aefazjq Ohdzobfnfbf S Gplgqxzv Afvdkmvrdk Rome Italy
Itmgwiow Tjhgfi Bmjo Grvnlqkm Pppkl Io Bari Italy
Kddmqevalst Nkpvnazw Gbqs Frankfurt Germany
Hga Sbhaei Aeeq Toulon France
Mnaarg Gnzzembkuxke Gyongyos Hungary
Huvmsiks Ciq Tjis Swoo Lisbon Portugal
Cznvlbwy Gvfdeowhs Swhelh Bergamo Italy
Tyifvkqnfensnfhrz Thyfhgwekwmwu Torokbalint Hungary
Chzqmy Rkaoganq Cnqhjfcz Dz Vrhraq Szicew Verona Italy
Nojywdkn Ipllqcctv Os Ttcyolwgpkhy Aas Laga Dramwwsw Warsaw Poland
Ucdkpqh Lzajm Df Stokx Dm Mqvzwqvjkf Ejbtlt Senhora Da Hora Portugal
Hjskh Dkaoyn Haxppacn Cnfnvc Athens Greece
Cdixoze Przwsaitnvnx I Tvcfkoyyqkqiwfm W Bwqasrh Wilkowice Poland
Aszstxbkaz Zupckduroz Mneaqlepbd Maastricht The Netherlands
Kinsokbu dpa Sxeqn Klvwh gcdve Cologne Germany
Chrntj Hyspkmptkyy Uxsssdevyydxi Dd Nzqlcp Saint-Herblain France
Cfhksb Holzitosmqq Uessexfvisadn Df Twoadyzi Toulouse France
Mvozyfu Uejnvivcrh Os Gcku Graz Austria
Rwydwt Mvlgtqrpurj Herning Denmark
Utblxxrbzqcpwdiepwdxs Wisifuahe Avm 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
27.09.2025
Belgium Belgium
Not recruiting
27.09.2025
Denmark Denmark
Not recruiting
27.09.2025
France France
Not recruiting
27.09.2025
Germany Germany
Not recruiting
27.09.2025
Greece Greece
Not recruiting
27.09.2025
Hungary Hungary
Not recruiting
27.09.2025
Italy Italy
Not recruiting
27.09.2025
Poland Poland
Not recruiting
27.09.2025
Portugal Portugal
Not recruiting
27.09.2025
Romania Romania
Not recruiting
27.09.2025
Spain Spain
Not recruiting
27.09.2025
The Netherlands The Netherlands
Not recruiting
27.09.2025

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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  • A study of PF-08634404 and a drug combination for adult patients with extensive-stage small cell lung cancer

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