NCT06008353Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 7 Mar 2023
- Start date
- 18 Jan 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Lung cancer
- NCT number
- NCT06008353
What you commit to
- Study type: Observational
- Planned participants: 60
- From 18 Jan 2024 to the primary completion date, 31 Aug 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncologia D'Or Unidade Esperança Pernambuco Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| Instituto D'Or de Pesquisa e Ensino RJ Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| A.C. Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| BP - A Beneficência Portuguesa de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.