Study comparing GSK5764227 and topotecan in adults with relapsed small cell lung cancer

3 1 1 1

What is this study about?

This study focuses on patients with Small Cell Lung Cancer (SCLC) that has returned after previous treatment. The study will compare two different treatments: a new experimental medication called GSK5764227, which is a type of drug known as a B7-H3 Antibody Drug Conjugate, and an established cancer medication called topotecan. The purpose is to determine how well the new treatment works compared to the standard treatment in fighting the cancer.

The study involves patients whose lung cancer has already been treated with platinum-based chemotherapy combined with immunotherapy but has since returned. Both medications in this study will be given through intravenous infusion (delivered directly into a vein). GSK5764227 will be given at doses up to 8 milligrams per kilogram of body weight, while topotecan will be given at doses up to 1.5 milligrams per square meter of body surface area.

This is an open-label study, which means both the doctors and patients will know which treatment is being given. The treatment period may last up to 24 months, during which time doctors will monitor how well the cancer responds to the treatment and track the overall survival of patients. Throughout the study, patients will have regular check-ups to monitor their health and assess how well the treatment is working.

1 Initial evaluation

Your eligibility for the study will be confirmed based on a diagnosis of extensive stage small cell lung cancer

Medical tests will verify that you have received previous treatment with platinum-based therapy combined with immunotherapy for at least 2 cycles

Confirmation that you have at least one measurable tumor outside the brain

Assessment of your physical condition using the ECOG scale (a measure of daily activity ability) showing a score of 0 or 1

Laboratory tests to check your organ function, performed 3-5 days before the start of treatment

2 Treatment assignment

You will be randomly assigned to receive either GSK5764227 or topotecan

Both medications will be administered through an intravenous infusion (directly into your vein)

3 Treatment period

Regular treatment sessions will be scheduled according to your assigned medication plan

Your tumor response will be monitored through imaging tests

Regular assessments will track your overall health status

4 Follow-up period

Your health status will continue to be monitored after completing the treatment

The study is expected to continue until September 2028

Who Can Join the Study?

  • Must have confirmed small cell lung cancer (SCLC) that has spread beyond the lung (extensive stage), proven by tissue or cell examination
  • Must have previously received only one treatment that included both:
    • platinum-based therapy (a type of chemotherapy) for at least 2 cycles
    • PD-(L)1 inhibitor (a type of immunotherapy that helps your immune system fight cancer)
  • Must have at least one tumor that can be measured outside the brain
  • Must have good physical function ability, rated as ECOG 0 or 1 (able to carry out all or most daily activities), with no worsening in the 2 weeks before starting treatment
  • Must have normal functioning of major organs (such as liver, kidneys, bone marrow). Tests must be done:
    • Initial screening tests: 3-5 days before treatment
    • Final tests: within 24 hours before first treatment
  • Must be an adult (18 years or older)
  • Can be either male or female

Who Cannot Join the Study?

  • Prior treatment with topotecan (a chemotherapy drug)
  • Known active brain metastases (cancer that has spread to the brain)
  • History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Significant heart problems including uncontrolled high blood pressure, unstable heart disease, or heart failure
  • Active or chronic infections, including HIV, Hepatitis B, or Hepatitis C
  • Major surgery within 4 weeks before starting the study treatment
  • Participation in another clinical trial within 4 weeks before starting this study
  • Pregnant or breastfeeding women
  • Known allergies to the study medications or their components
  • Severe kidney or liver problems
  • Any condition that could affect the ability to follow study procedures or interpret results
  • Use of medications that could interact with the study drugs
  • Mental conditions that could affect the ability to give informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
University Of Debrecen Debrecen Hungary
Hospital Vall d’Hebron Barcelona Spain
Institutul Regional De Oncologie Iasi Iasi Romania
Beaumont Hospital Dublin Ireland
Hospital Clinic De Barcelona Barcelona Spain
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Karolinska University Hospital Solna Sweden
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Kliniken der Stadt Koeln gGmbH Cologne Germany
Universitaetsklinikum Muenster AöR Munster Germany
Athens Medical Center S.A. Thessaloniki Greece
Klinikum der Universitaet Muenchen AöR Munich Germany
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Centre Leon Berard Lyon France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Institut Gustave Roussy Villejuif France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Marques De Valdecilla Santander Spain
Hospital Del Mar Barcelona Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz Madrid Spain
University General Hospital Of Heraklion Heraklion Greece
CHU Grenoble Alpes La Tronche France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Bacs-Kiskun Varmegyei Oktatokorhaz Kecskemet Hungary
Koranyi National Institute For Pulmonology Budapest Hungary
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie Homburg Germany
Centre Hospitalier Et Universitaire De Limoges Limoges France
Universitaetsklinikum Regensburg AöR Regensburg Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Comite Entreprise Paul Papin Angers France
Azienda Ospedaliera Universitaria Senese Siena Italy
Champalimaud Clinical Centre Lisbon Portugal
Hopital Ambroise Pare Boulogne-Billancourt France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Cracow Poland
Cliniche Gavazzeni S.p.A. Bergamo Italy
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Military Medical Academy Pleven Bulgaria
Pohjois-Savon hyvinvointialue Kuopio Finland
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Universitaetsklinikum Augsburg Augsburg Germany
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E. Coimbra Portugal
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Henry Dunant Hospital Center Athens Greece
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Przemysl Poland

Other Sites

Site Name City Country Status
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Complex Oncology Center Ruse EOOD Ruse Bulgaria
Fqfkidgjgd Hqckyose Hjgejtraeh Georgsmarienhütte Germany
Kfoadrqb Carofqwy gosef Chemnitz Germany
Psgakgpmvpsrv Obetqxnuv Oldenburg In Holstein Germany
Htx Shnorq Avii Toulon France
Spj Snembzn Hmtkrphm Gkyixyx Akixuaernwq agr Ojuiypqlfkb Hvcoxhgt oo Acxvyb Athens Greece
Fuycdlkpbhbb Tpxsqkxakmhnsifz Farkasgyepu Hungary
Mmkqdw Geffedkyrlqc Gyongyos Hungary
Mcvh Smrgbau Ludn Sofia Bulgaria
Lxrxxpof Olrpdqabzxpe Sgurhudiiugvkdwti Luebeck Germany
Abwiurl Uem Tcvyius nzis ovwez Leghorn Italy
Egtyviziigpe Kusxyynfwsszrcjffsiuwke Hajrggurxqmhiibgsytb gaadh Herne Germany
Vkwvkiqwxhsvgjddptiirmpeleugkna gom Karlsruhe Germany
Ohmmnts Secplw Timisoara Romania
Wwbfqqqpaftlj Crochnz Pghwjwnnifot I Tyqzrjjkufktbei Ifk Eedogtg I Jejgwqy Zripypoew Poznan Poland
Rgbktl Bztdq Klkiaxlivrz Gpdy Stuttgart Germany
Hweidd Ktnznsdv Bjv Sukzuu Gike Bad Saarow Germany
Oxomtuh Shtihn Craiova Romania
Rjstjycvraiv Cfhxst Cunr Shtdkx Floresti Romania
Vuewa Cmppwvl Hfsitlzm Vaasa Finland
Magewyahccltk Hgivmysi ftd Aqyfll Teizlvbbb Hzepo art Bueyo Ezo Pleven Bulgaria
Mskehhorzwmwudjym Hrgggmvt Fld Aayrnm Trmdynjok Pczh Hkugvuvd Lmzg Branipole Bulgaria
Mevdnsytnxw Czabjyy Lqcjquad Cipvev Pbkr I Glofusjc Otwock Poland
Lqhidrjsmecwtbof Iqetpzitvzi Immenhausen Germany

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
09.02.2026
Finland Finland
Recruiting
09.02.2026
France France
Recruiting
09.02.2026
Germany Germany
Recruiting
09.02.2026
Greece Greece
Recruiting
09.02.2026
Hungary Hungary
Recruiting
09.02.2026
Ireland Ireland
Not yet recruiting
09.02.2026
Italy Italy
Recruiting
09.02.2026
Poland Poland
Not yet recruiting
09.02.2026
Portugal Portugal
Recruiting
09.02.2026
Romania Romania
Recruiting
09.02.2026
Spain Spain
Recruiting
09.02.2026
Sweden Sweden
Recruiting
09.02.2026

Trial locations

Investigated Drugs:

GSK5764227 is an antibody drug conjugate (ADC) that targets B7-H3, which is being studied as a potential treatment for small cell lung cancer. This medication is designed to specifically target cancer cells while minimizing damage to healthy cells.

Topotecan is an established chemotherapy medication used to treat various types of cancer, including small cell lung cancer. It works by interfering with the cancer cells’ ability to divide and grow. This medication is being used as the comparison treatment in this study.

Small Cell Lung Cancer – A fast-growing type of lung cancer that develops in the lung tissues, specifically in the bronchi. It usually starts in the cells that look like oats (oat cell cancer) or in mixed smaller cells. The cancer cells multiply quickly and form large masses in the lungs, often spreading early to other parts of the body. This condition is characterized by rapid cell division and growth, making it distinct from other forms of lung cancer. Small cell lung cancer typically begins in the central part of the lungs and can cause symptoms such as persistent cough, chest pain, and breathing difficulties.

Trial ID:
2025-521627-78-00
Protocol code:
223674
NCT ID:
NCT07099898
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Testing Tarlatamab in Patients with Advanced Small-Cell Lung Cancer Who Have Poor Physical Condition

    Recruiting

    2 1 1
    Investigated Drugs:
    Germany
  • Study comparing tarlatamab with topotecan in patients with relapsed small cell lung cancer after first-line chemotherapy

    Not recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark France Germany +9