Clinical trial NCT06008353: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Extensive-stage Small-cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Demographic Characteristics of the Cohort
timeFrame: Baseline.
measure: Clinical Characteristics of the Cohort
timeFrame: Baseline.
measure: Comparison of Demographic and Clinical Characteristics between Recurrent and Newly Diagnosed CPPC-EE Patients
timeFrame: During the cohort follow-up, an average of 24 months, starting from diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
state: Bahia
city: Recife
country: Brazil
facility: Oncologia D'Or Unidade Esperança Pernambuco
state: Pernambuco
city: Rio De Janeiro
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino RJ
city: São Paulo
country: Brazil
facility: BP - A Beneficência Portuguesa de São Paulo
city: São Paulo
country: Brazil
facility: A.C. Camargo Cancer Center
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Mauro Zukin
role: PRINCIPAL_INVESTIGATOR
References: