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Active (not recruiting) Phase 1 NCT05361395

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

Phase 1 – testing safety in a small group of people
Conditions: Extensive Stage Small Cell Lung Cancer

Sponsor: Amgen

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Overview
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.
Who can participate
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.
Locations 14
Australia (1)
Chris OBrien Lifehouse
Camperdown , New South Wales
Belgium (1)
Universitair Ziekenhuis Antwerpen
Edegem
Canada (1)
Princess Margaret Cancer Centre
Toronto , Ontario
Denmark (1)
Rigshospitalet
Copenhagen
France (1)
Centre Leon Berard
Lyon
Israel (1)
Rambam Medical Center
Haifa
Italy (1)
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro
Japan (1)
National Cancer Center Hospital East
Kashiwa-shi , Chiba
Netherlands (1)
Universitair Medisch Centrum Groningen
Groningen
South Korea (1)
Seoul National University Hospital
Seoul
Spain (1)
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona , Catalonia
Switzerland (1)
Universitaetsspital Basel
Basel
Taiwan (1)
National Cheng Kung University Hospital
Tainan
United States (1)
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.08.2022
Completion date
28.08.2028
Registry ID
NCT05361395
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.