First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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)
Number of Participants with a Dose Limiting Toxicity (DLT) — 24 months
Number of Participants with Treatment-emergent Adverse Events (TEAE) — 24 months
Number of Participants with Treatment-related Adverse Events — 24 months
Number of Participants with Clinically Significant Changes in Vital Signs — 24 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements — 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests — 24 months
Trial sites (44)
Facility
City
Region
Status
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.
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.
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