EDUR-BRA: 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
Study Details
Study Description
Brief Summary
The central objective of this study is to assess the efficacy and safety of durvalumab-based regimens in 1L treatment of ES-SCLC Brazilian patients. By collecting patient's baseline and medical history data, the study will also provide relevant demographic information about SCLC patients in the private health setting in Brazil, which has not been extensively explored in the past.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Other: Observational study
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
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Outcome Measures
Primary Outcome Measures
- Demographic Characteristics of the Cohort [Baseline.]
This measure encompasses relevant demographic information of the patients included in the cohort, including median age at diagnosis, gender distribution, smoking history, and World Health Organization Performance Status (WHO PS) score. These details will provide a comprehensive understanding of the patient profile within the cohort.
- Clinical Characteristics of the Cohort [Baseline.]
This measure encompasses relevant clinical information of the patients included in the cohort, including presence of hepatic and cerebral metastases, type of platinum used in first-line (1L) treatment, and diagnostic stage (III vs. IV) of CPPC-EE. These details will provide a comprehensive understanding of the patient profile within the cohort.
- Comparison of Demographic and Clinical Characteristics between Recurrent and Newly Diagnosed CPPC-EE Patients [During the cohort follow-up, an average of 24 months, starting from diagnosis.]
This measure focuses on comparing patients with recurrent CPPC-EE and those newly diagnosed. The incidence of disease recurrence and distinct demographic and clinical characteristics between these groups, such as age, gender, smoking history, World Health Organization Performance Status (WHO PS) score, presence of hepatic and cerebral metastases, type of platinum used in first-line (1L) treatment, and diagnostic stage, will be analyzed and reported. This will allow for a deeper understanding of differences between recurrent and newly diagnosed patients.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a documented diagnosis of ES-SCLC (newly diagnosed patients, as well as limited stage relapsed patients, are eligible);
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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);
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Male or female adult patients ≥ 18 years of age (as per local Durvalumab approved label);
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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 Criteria:
- 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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Latin American Cooperative Oncology Group
- AstraZeneca
Investigators
- Principal Investigator: Mauro Zukin, Latin American Cooperative Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LACOG 0322
- D4191R00053