Status:
ACTIVE_NOT_RECRUITING
A Real-World Assessment of the Demographic, Clinical Characteristics and Outcomes of a Brazilian Cohort of Previously Untreated Extensive Stage-Small Cell Lung Cancer Receiving Durvalumab Combined With Platinum-Etoposide in (ES-SCLC) in Brazil
Lead Sponsor:
AstraZeneca
Conditions:
Extensive-stage Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The central objective of this study is to characterize the demographic of an ES-SCLC Brazilian cohort treated with durvalumab. Secondarily, to assess the outcomes of durvalumab-based regimens in 1L tr...
Eligibility Criteria
Inclusion
- Have a documented diagnosis of ES-SCLC (newly diagnosed patients, as well as limited stage relapsed patients, are eligible);
- Have been treated with a durvalumab-based regimen for 1L ES-SCLC in the past (retrospective) OR is currently being treated with a durvalumab-based regimen for 1L ES-SCLC (prospective);
- Male or female adult patients ≥ 18 years of age (as per local Durvalumab approved label);
- Provision of consent in a signed informed consent form (ICF) (allowing for data to be captured from existing medical records). If the patient´s data is entirely retrospective (i.e., the patient already presented progression, death, or completed 18 months of durvalumab-based treatment), the ICF may be waived, as decided by the local ethics committee.
Exclusion
- Since the study is observational, there are no Exclusion Criteria. If the patient meets all the Inclusion Criteria, he/she will be eligible for the study.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06008353
Start Date
January 18 2024
End Date
August 31 2026
Last Update
December 19 2024
Active Locations (5)
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1
ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
Salvador, Estado de Bahia, Brazil, 41.950-640
2
Oncologia D'Or Unidade Esperança Pernambuco
Recife, Pernambuco, Brazil, 50.070-480
3
Instituto D'Or de Pesquisa e Ensino RJ
Rio de Janeiro, Brazil, 22.281-100
4
BP - A Beneficência Portuguesa de São Paulo
São Paulo, Brazil, 01.323-030