Study comparing tarlatamab with topotecan in patients with relapsed small cell lung cancer after first-line chemotherapy

3 1 1 1

What is this study about?

This study focuses on treating Small Cell Lung Cancer (SCLC) that has returned after initial treatment with platinum-based chemotherapy. The study compares two treatment approaches: a new medication called tarlatamab versus standard care treatments that include topotecan, dexamethasone, tocilizumab, and siltuximab. The purpose is to determine if tarlatamab helps patients live longer compared to standard treatments.

Tarlatamab is given through an intravenous infusion, which means it is delivered directly into a vein. The standard care medications may be given either as infusions into a vein or as oral capsules, depending on the specific medication. During treatment, doctors will monitor how well the medications work and track any changes in the cancer.

Throughout the study, healthcare providers will assess various aspects of participants’ health, including chest pain, coughing, breathing difficulties, and overall well-being. They will also monitor how the disease responds to treatment and track how long participants survive after starting treatment. The study medication or standard care will be continued as long as it provides benefit to the participant and is well tolerated.

1 Initial screening and assignment

Your eligibility for the study will be evaluated based on specific criteria, including confirmation of small cell lung cancer that has returned or progressed after platinum-based treatment.

If eligible, you will be randomly assigned to receive either tarlatamab or standard care treatment.

2 Treatment administration

You will receive treatment through intravenous infusion (medication given directly into a vein).

The treatment will be either tarlatamab or one of the standard care medications (topotecan, dexamethasone, tocilizumab, or siltuximab).

The treatment will continue until your disease progresses or other stopping criteria are met.

3 Regular assessments

Your health status will be evaluated every 6 weeks for the first 18 weeks.

Assessments will include monitoring of chest pain, cough, chest tightness, and your overall physical function.

Regular scans will be performed to check if your disease has progressed.

4 Long-term follow-up

Your health status will continue to be monitored throughout the study period.

The study is expected to continue until March 2028.

Your participation will help evaluate how well tarlatamab works compared to standard treatments in extending survival time.

Who Can Join the Study?

  • Must be able to provide informed consent to participate in the study
  • Must be at least 18 years old or meet the legal adult age requirement in your country (whichever is higher)
  • Must have confirmed small cell lung cancer that has returned or worsened after previous treatment
  • Must have had disease progression or recurrence after receiving one platinum-based treatment (a specific type of chemotherapy)
  • Must have measurable disease that can be evaluated through imaging within 21 days before starting the study
  • Must have good physical functioning ability, scoring either 0 (fully active) or 1 (restricted in strenuous activity but able to carry out light work) on the ECOG scale
  • Must have a life expectancy of at least 12 weeks
  • Must have adequate organ function (meaning your major organs are working well enough to participate safely)

Who Cannot Join the Study?

  • Prior treatment with any DLL3-targeted therapy (a specific type of targeted cancer treatment)
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • History of another cancer within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions, including:
    • Heart attack within the past 6 months
    • Unstable angina (chest pain)
    • Severe heart failure
  • Active, uncontrolled infections requiring systemic treatment
  • Known positive test for HIV, active hepatitis B, or active hepatitis C
  • Pregnant or breastfeeding women
  • Any serious medical condition that could interfere with study participation
  • Participation in another clinical trial within 30 days before starting this study
  • Known allergic reactions to similar medications used in this study
  • Significant psychiatric disorders that could affect ability to comply with the study protocol

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
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Alexandra Hospital Athens Greece
Academisch Ziekenhuis Leiden Leiden The Netherlands
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Brno Brno Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Cliniche Gavazzeni S.p.A. Bergamo Italy
St. Luke’s Hospital S.A. Thessaloniki Greece
Universitaetsklinikum Wuerzburg AöR Wuerzburg Germany
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Matrai Gyogyintezet Gyongyos Hungary
Institutul Regional De Oncologie Iasi Iasi Romania
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Jessa Ziekenhuis Hasselt Belgium
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Universitair Ziekenhuis Gent Gent Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Deutsches Herzzentrum Berlin Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Nemocnice AGEL Ostrava-Vitkovice a.s. Ostrava Czechia
Hospital Del Mar Barcelona Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Saint Savvas Oncology Hospital Athens Greece
Algemeen Ziekenhuis Delta Roeselare Belgium
Vitaz Sint-Niklaas Belgium
University General Hospital Of Heraklion Heraklion Greece
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
Beaumont Hospital Dublin Ireland
Hôpital Pontchaillou-CHU Rennes Rennes France
Hospital CUF Porto S.A. Porto Portugal
Thoracic General Hospital Of Athens I Sotiria Athens Greece
Olympion Therapeftirio General Clinic Of Patras S.A. Patras Greece
Ixnxwdmh Rnjrvonde Pxz Lc Seynbc Dmj Tykllz Dyjc Arvovxj Isxf Sldwyu Meldola Italy
Amntzn Mbbfedi Ceyfta Ssmk Thessaloniki Greece
Afranee Obrpvscdrzs Otenogba Rekhfdl Vuwxh Sjmil Cwkkfjrl Palermo Italy
Uzpnavdsqw Hwssouoi Czgskkb Cologne Germany
Abicmpqsuo Pquyvwmj Hdazmhsa Dc Mugalxtmx Marseille France
Eyzxpkp Usnrelcyxdli Mwunapb Cuxqxvy Rmzwphvma (byhsnkf Mfl Rotterdam The Netherlands
Hppsifop Dv Lz Slbao Cren I Sfnt Pbt Barcelona Spain
Uaklpoprafcyoaxqrmays Efwye Aph Essen Germany
Umdhptsvzhgd Mkoazsl Cixjsvf Gxrqqbzag Groningen The Netherlands
Ahizucw Okrolsrglde S Gyasglck Adtsebevtf Rome Italy
Hftskygm Vpar dobqrcph Barcelona Spain
Ipmamipz Cluor 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
15.09.2023
Belgium Belgium
Not recruiting
15.09.2023
Czechia Czechia
Not recruiting
15.09.2023
Denmark Denmark
Not recruiting
15.09.2023
France France
Not recruiting
15.09.2023
Germany Germany
Not recruiting
15.09.2023
Greece Greece
Not recruiting
15.09.2023
Hungary Hungary
Not recruiting
15.09.2023
Ireland Ireland
Not recruiting
15.09.2023
Italy Italy
Not recruiting
15.09.2023
Poland Poland
Not recruiting
15.09.2023
Portugal Portugal
Not recruiting
15.09.2023
Romania Romania
Not recruiting
15.09.2023
Spain Spain
Not recruiting
15.09.2023
The Netherlands The Netherlands
Not recruiting
15.09.2023

Trial locations

Tarlatamab is an investigational medication being studied for treating small cell lung cancer in patients whose cancer has returned after initial platinum-based chemotherapy. It is a targeted therapy designed to find and attack cancer cells. The medication is being compared to standard treatments currently used for this type of cancer.

Standard of Care (SOC) refers to the current best available treatments that doctors typically use to treat small cell lung cancer after initial chemotherapy has failed. These may include various approved chemotherapy medications that are already established as treatment options for this condition.

Small Cell Lung Cancer (SCLC) – A fast-growing type of lung cancer that develops in the lungs’ small cells, typically in the bronchi. It is characterized by rapid cell division and early spread throughout the body. The cancer cells are smaller in size than most other types of lung cancer cells, which gives the disease its name. SCLC typically starts in the airways of the lungs and can spread quickly to other parts of the body. The condition often develops in people with a history of smoking.

Trial ID:
2022-502669-14-00
Protocol code:
20210004
NCT ID:
NCT05740566
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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

    Recruiting

    3 1 1 1
    Investigated drugs:
    Bulgaria Finland France Germany Greece Hungary +7
  • Testing Tarlatamab in Patients with Advanced Small-Cell Lung Cancer Who Have Poor Physical Condition

    Recruiting

    2 1 1
    Investigated drugs:
    Germany