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Clinical Trials in Germany / NCT05361395
Active, not recruiting Phase 1

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT05361395 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Phase 1
Started
2022-08-24
Last updated
2026-09-09

Condition(s) studied

Extensive Stage Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Tarlatamab →Carboplatin →Etoposide →Atezolizumab →Durvalumab →

Tarlatamab: Tarlatamab will be administered as an intravenous (IV) infusion.

Carboplatin: Carboplatin will be administered as an intravenous (IV) infusion.

Etoposide: Etoposide will be administered as an intravenous (IV) infusion.

Atezolizumab: Atezolizumab will be administered as an intravenous (IV) infusion.

Durvalumab: Durvalumab will be administered as an intravenous (IV) infusion.

Study summary

This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age greater than or equal to 18 years old at the same time of signing the informed consent. * Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC. * Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted. * Eastern Cooperative Oncology Group (ECOG) 0 to 1. * Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria. * Adequate organ function as defined in protocol. Exclusion Criteria: * History of other malignancy within the past 2 years with exceptions. * Major surgery within 28 days of study day 1. * Untreated or symptomatic brain metastases and leptomeningeal disease. * Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents. * History of immune-related colitis. * History or evidence of interstitial lung disease or active, non-infectious pneumonitis. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. * Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment * Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint * NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for \>24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required. * History of hypophysitis or pituitary dysfunction. * History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation. * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
University of Southern California, Norris Comprehensive Cancer Center Los Angeles California
Christiana Care Health Services Newark Delaware
Henry Ford Health System Detroit Michigan
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
New York University Grossman School of Medicine and New York University Langone Hospitals New York New York
The University of North Carolina at Chapel Hill Chapel Hill North Carolina
Avera Cancer Institute Sioux Falls South Dakota
Swedish Cancer Institute Medical Oncology Seattle Washington
West Virginia University Health Sciences Center Morgantown West Virginia
Chris OBrien Lifehouse Camperdown New South Wales
Universitair Ziekenhuis Antwerpen Edegem Belgium
Algemeen Ziekenhuis Maria Middelares Ghent Belgium
Jessa Ziekenhuis - Campus Virga Jesse Hasselt Belgium
AZ Delta Campus Rumbeke Roeselare Belgium
Princess Margaret Cancer Centre Toronto Ontario
CHU de Quebec Hopital de l Enfant Jesus Québec Quebec
Rigshospitalet Copenhagen Denmark
Centre Leon Berard Lyon France
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec Saint-Herblain France
Gustave Roussy Villejuif France
Universitaetsklinikum Dresden Dresden Germany
Universitaetsklinikum Essen Essen Germany
Universitaetsklinikum Freiburg Freiburg im Breisgau Germany
Rambam Medical Center Haifa Israel
Hadassah Ein-Kerem Medical Center Jerusalem Israel
Rabin Medical Center Petah Tikva Israel
Sheba Medical Center Ramat Gan Israel
Azienda Ospedaliera Universitaria Renato Dulbecco Catanzaro Italy
Fondazione IRCCS San Gerardo dei Tintori Monza (MB) Italy
Istituto Nazionale Tumori Regina Elena Rome Italy
National Cancer Center Hospital East Kashiwa-shi Chiba
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Koto-ku Tokyo
Universitair Medisch Centrum Groningen Groningen Netherlands
Seoul National University Hospital Seoul South Korea
Asan Medical Center Seoul South Korea
Samsung Medical Center Seoul South Korea
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol Badalona Catalonia
Hospital Universitari Vall d Hebron Barcelona Catalonia
Hospital Universitario 12 de Octubre Madrid Spain
Universitaetsspital Basel Basel Switzerland

+ 4 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Imfinzi (durvalumab) drug profile →

More Amgen trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05361395 on ClinicalTrials.gov ↗ ← All trials in Germany