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
NCT ID: NCT06008353
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
60 participants
OBSERVATIONAL
2024-01-18
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Adult patients newly diagnosed with ES-SCLC
The study will include consecutive adult patients newly diagnosed with ES-SCLC (patients with the recurrent limited stage disease are also eligible).
Observational study
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
Interventions
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Observational study
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mauro Zukin
Role: PRINCIPAL_INVESTIGATOR
Latin American Cooperative Oncology Group
Locations
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ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
Salvador, Estado de Bahia, Brazil
Oncologia D'Or Unidade Esperança Pernambuco
Recife, Pernambuco, Brazil
Instituto D'Or de Pesquisa e Ensino RJ
Rio de Janeiro, , Brazil
BP - A Beneficência Portuguesa de São Paulo
São Paulo, , Brazil
A.C. Camargo Cancer Center
São Paulo, , Brazil
Countries
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Other Identifiers
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D4191R00053
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
D4191R00053
Identifier Type: -
Identifier Source: org_study_id