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

Status

Completed

Conditions

Intervention / Treatment

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

  • France
      • Paris, France
        • Institut Curie
      • Villefranche-sur-Saône, France
        • Villefranche-Sur-Saône - CH

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
age
8 months
demographic and clinical characteristics of patients
Time Frame: 8 months
sex
8 months
demographic and clinical characteristics of patients
Time Frame: 8 months
clinical stage
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
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
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
8 months
Pattern of tumor progression
Time Frame: 8 months
site of disease progression after treatment with lurbinectedin
8 months
Duration of treatment with lurbinectedin beyond progression
Time Frame: 8 months
time between first occurrence of disease progression and treatment discontinuation
8 months
Adverse Drug Reaction
Time Frame: 8 months
maximal grade 3-4-5 treatment-related adverse events (SAEs, TRAEs), and immune-related events will be recorded for each patient
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Collaborators

PharmaMar
Groupe Francais De Pneumo-Cancerologie

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.

General Publications

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

Keywords

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.

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