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 (EDUR-BRA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Extensive-stage Small-cell Lung Cancer
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 22.281-100
    • Instituto D'Or de Pesquisa e Ensino RJ
  • São Paulo, Brazil, 01.323-030
    • BP - A Beneficencia Portuguesa de São Paulo
  • São Paulo, Brazil, 01.509-001
    • A.C. Camargo Câncer Center
  • Bahia
    • Salvador, Bahia, Brazil, 41.950-640
      • ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50.070-480
      • Oncologia D'Or Unidade Esperança Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male or female patients (aged 18 years or older) with histologically- or cytologically-documented ES-SCLC receiving a durvalumab-based regimen as a first-line treatment.

Description

Inclusion Criteria:

• 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 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Demographic and Clinical Characteristics between Recurrent and Newly Diagnosed CPPC-EE Patients	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.	During the cohort follow-up, an average of 24 months, starting from diagnosis.
Demographic Characteristics of the Cohort	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.	Baseline.
Clinical Characteristics of the Cohort	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.	Baseline.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Mauro Zukin, Latin American Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: D4191R00053 (Other Grant/Funding Number: AstraZeneca)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No