RW Effectiveness of Lurbinectedin in Extensive Stage SCLC (LURBICLIN)
January 5, 2023 updated by: Intergroupe Francophone de Cancerologie Thoracique
Real-world Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Lurbinectedin as Part of the French Early Access Program (ATU).
LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program.
LURBICLIN will evaluate effectiveness and safety of lurbinectedin in real-world conditions.
Study Overview
Detailed Description
LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program.
LURBICLIN will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received lurbinectedin as part of the French Early Access Program (ATU).
Previous and subsequent treatments (treatment delivered immediately after treatment with lurbinectedin) will be recorded.
Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.
Study Type
Observational
Enrollment (Actual)
312
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France
- Institut CURIE
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Villefranche-sur-Saône, France
- Villefranche-Sur-Saône - CH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).
Description
Inclusion Criteria:
- Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer
- Patients who were informed about the study and accepted for their data to be collected
- Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).
- Selection period spans from June 2020 until March 2021 for initiation of treatment with lurbinectedin.
Exclusion Criteria:
- Patients enrolled in a clinical trial assessing treatment with lurbinectedin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
demographic and clinical characteristics of patients
Time Frame: 8 months
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age
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8 months
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demographic and clinical characteristics of patients
Time Frame: 8 months
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sex
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8 months
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|
demographic and clinical characteristics of patients
Time Frame: 8 months
|
clinical stage
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8 months
|
|
demographic and clinical characteristics of patients
Time Frame: 8 months
|
prior therapy
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: 8 months
|
OS is defined as the time from the first dose of treatment with lurbinectedin to death from any cause
|
8 months
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Real-world progression-free survival
Time Frame: 8 months
|
time from first dose of treatment with lurbinectedin to first occurrence of disease progression or death from any cause during the study
|
8 months
|
|
Best response
Time Frame: 8 months
|
best response recorded from the start of treatment with lurbinectedin until disease progression or start of further anti-cancer treatment
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8 months
|
|
Duration of treatment
Time Frame: 8 months
|
time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with lurbinectedin
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8 months
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|
Pattern of tumor progression
Time Frame: 8 months
|
site of disease progression after treatment with lurbinectedin
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8 months
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Duration of treatment with lurbinectedin beyond progression
Time Frame: 8 months
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time between first occurrence of disease progression and treatment discontinuation
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8 months
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Adverse Drug Reaction
Time Frame: 8 months
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maximal grade 3-4-5 treatment-related adverse events (SAEs, TRAEs), and immune-related events will be recorded for each patient
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8 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Nicolas Girard, Institut CURIE
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
December 15, 2022
Study Completion (Actual)
December 15, 2022
Study Registration Dates
First Submitted
March 4, 2022
First Submitted That Met QC Criteria
March 16, 2022
First Posted (Actual)
March 17, 2022
Study Record Updates
Last Update Posted (Estimate)
January 6, 2023
Last Update Submitted That Met QC Criteria
January 5, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFCT-2105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.