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
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Interventions
- Other: Observational study
- Registration Number
- NCT06008353
- Lead Sponsor
- Latin American Cooperative Oncology Group
- 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 treatment of ES-SCLC Brazilian patients from the private health care setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult patients newly diagnosed with ES-SCLC Observational study The study will include consecutive adult patients newly diagnosed with ES-SCLC (patients with the recurrent limited stage disease are also eligible).
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Oncologia D'Or Unidade Esperança Pernambuco
🇧🇷Recife, Pernambuco, Brazil
ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
🇧🇷Salvador, Bahia, 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