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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 (EDUR-BRA)

AstraZeneca logo

AstraZeneca

Status

Active, not recruiting

Conditions

Extensive-stage Small-cell Lung Cancer

Treatments

Other: Observational study

Study type

Observational

Funder types

Industry

Identifiers

NCT06008353
D4191R00053 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

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).
Treatment:
Other: Observational study

Trial contacts and locations

5

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Central trial contact

AstraZeneca Clinical Study Information Center; Laura Voelcker

Data sourced from clinicaltrials.gov

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