Clinical trial · Observational
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
NCT06008353CI-TRIAL-00083942EDUR-BRAactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult patients newly diagnosed with ES-SCLC
- description
- The study will include consecutive adult patients newly diagnosed with ES-SCLC (patients with the recurrent limited stage disease are also eligible).
- interventionNames
- Other: Observational study
Primary outcomes (3)
- measure
- Demographic Characteristics of the Cohort
- timeFrame
- Baseline.
- description
- 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.
- measure
- Clinical Characteristics of the Cohort
- timeFrame
- Baseline.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.