Extensive-stage Small-cell Lung CancerEDUR-BRANCT06008353
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 of Extensive-stage Small-cell Lung Cancer, run by AstraZeneca at 5 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Observational study
- How many people
- 60 participants
- Where
- 5 sitesBrazil
- Study dates
- 18 Jan 2024to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Oncologia D'Or Unidade Esperança Pernambuco
Recife, Pernambuco, 50.070-480
Instituto D'Or de Pesquisa e Ensino RJ
Rio de Janeiro, 22.281-100
ÉTICA Clínica AMO - Assistência Multidisciplinar em Oncologia
Salvador, Estado de Bahia, 41.950-640
BP - A Beneficência Portuguesa de São Paulo
São Paulo, 01.323-030
A.C. Camargo Cancer Center
São Paulo, 01.509-001
About this study
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
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Observational study
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline.
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.
Measured: Baseline.
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.
Measured: During the cohort follow-up, an average of 24 months, starting from diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start18 Jan 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mauro Zukin, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008353
- Sponsor's protocol ID
- D4191R00053
- Other IDs
- D4191R00053
- Acronym
- EDUR-BRA
- Status last verified
- Dec 2024
- First submitted
- 7 Mar 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06008353
- Acronym / sponsor ID
- EDUR-BRA / D4191R00053
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients newly diagnosed with ES-SCLC | – | Other: Observational studyThe study will include consecutive adult patients newly diagnosed with ES-SCLC (patients with the recurrent limited stage disease are also eligible). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyThis is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. | Other | Adult patients newly diagnosed with ES-SCLC |
Primary outcome
Demographic Characteristics of the Cohort
Time frame: Baseline.
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.
Clinical Characteristics of the Cohort
Time frame: Baseline.
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.
Comparison of Demographic and Clinical Characteristics between Recurrent and Newly Diagnosed CPPC-EE Patients
Time frame: During the cohort follow-up, an average of 24 months, starting from diagnosis.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Zukin principal investigator
Latin American Cooperative Oncology Group
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extensive-stage Small-cell Lung Cancer, run by AstraZeneca at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Characteristics of the Cohort (time frame: Baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.