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Trial 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
NCT ID:
NCT06008353
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Observational study
Description:
This is an observational study; patients will not be exposed to clinical interventions
different from those belonging to the standard of care.
Arm group label:
Adult patients newly diagnosed with ES-SCLC
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
Address:
City:
Salvador
Zip:
41.950-640
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Aknar Freire de Carvalho Calabrich
Email:
Principal Investigator
Facility:
Name:
Oncologia D'Or Unidade Esperança Pernambuco
Address:
City:
Recife
Zip:
50.070-480
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Carla Rameri Alexandre Silva de Azevedo
Email:
Principal Investigator
Facility:
Name:
Instituto D'Or de Pesquisa e Ensino RJ
Address:
City:
Rio De Janeiro
Zip:
22.281-100
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Mauro Zukin
Email:
Principal Investigator
Facility:
Name:
BP - A Beneficência Portuguesa de São Paulo
Address:
City:
São Paulo
Zip:
01.323-030
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Marcelo Petrocchi Corassa
Email:
Principal Investigator
Facility:
Name:
A.C. Camargo Cancer Center
Address:
City:
São Paulo
Zip:
01.509-001
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Vladmir Cláudio Cordeiro de Lima
Email:
Principal Investigator
Start date:
January 18, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06008353
