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A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
330 patients around the world
Available in Argentina, United States, Brazil
Amgen
3Research sites
330Patients around the world
This study is for people with
Lung cancer
Small cell lung carcinoma
Requirements for the patient
To 99 Years
All Gender
Medical requirements
- Participant has provided informed consent before initiation of any study-specific activities/procedures.Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.Measurable disease as defined per RECIST 1.1.Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.Minimum life expectancy ≥ 12 weeks.
- Participants can have no history of other malignancy in the last 2 years.Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.They will have no history of severe or life-threatening events to immune-mediated therapy.History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.They will have no active autoimmune or inflammatory disorders.Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.History of solid organ transplant.They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
Sites
Sanatorio Parque - Rosario
Recruiting
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
StudyDeLLphi-312
SponsorAmgen
Study typeInterventional
Conditions
Small cell lung carcinoma
Requirements
To 99 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07005128
