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Active, not recruitingNCT06008353EDUR-BRAUpdated Dec 19, 2024

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

An observational study in Extensive-stage Small-cell Lung Cancer, sponsored by AstraZeneca. Active, not recruiting at 5 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
60
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Extensive-stage Small-cell Lung Cancer
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In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 124 observational studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adult patients newly diagnosed with ES-SCLC

    The study will include consecutive adult patients newly diagnosed with ES-SCLC (patients with the recurrent limited stage disease are also eligible).

    Other: Observational study

Interventions

  • OtherObservational study

    This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline.

  2. 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.

    Time frame: Baseline.

  3. 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.

    Time frame: During the cohort follow-up, an average of 24 months, starting from diagnosis.

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Study locations

5 sites
  • ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
    Salvador, Estado de Bahia 41.950-640, Brazil
  • Oncologia D'Or Unidade Esperança Pernambuco
    Recife, Pernambuco 50.070-480, Brazil
  • Instituto D'Or de Pesquisa e Ensino RJ
    Rio de Janeiro, 22.281-100, Brazil
  • BP - A Beneficência Portuguesa de São Paulo
    São Paulo, 01.323-030, Brazil
  • A.C. Camargo Cancer Center
    São Paulo, 01.509-001, Brazil
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06008353
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 23, 2023
Start date
Jan 18, 2024
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Dec 19, 2024

Study contacts

Mauro Zukin
principal investigator · Latin American Cooperative Oncology Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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