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

Extensive-stage Small-cell Lung Cancer Clinical Trial

— EDUR-BRA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06008353
• Other study ID #: LACOG 0322
• Secondary ID: D4191R00053
• Status: Not yet recruiting
• Start date: November 17, 2023
• Est. completion date: September 15, 2026

Study information

• Verified date: October 2023
• Source: Latin American Cooperative Oncology Group
• Contact: Laura Mendonça
• Phone: +55 51 3384 5334
• Email: laura.mendonca[@]lacogcancerresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 15, 2026
• Est. primary completion date: September 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Brazil	Oncologia D'Or Unidade Esperança Pernambuco	Recife	Pernambuco
Brazil	Instituto D'Or de Pesquisa e Ensino RJ	Rio De Janeiro
Brazil	ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia	Salvador	Bahia
Brazil	A.C. Camargo Cancer Center	São Paulo
Brazil	BP - A Beneficência Portuguesa de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	AstraZeneca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.