LURBICLIN: RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

Sponsor
Intergroupe Francophone de Cancerologie Thoracique (Other)
Overall Status
Recruiting
CT.gov ID
NCT05285033
Collaborator
Groupe Français de Pneumo-Cancérologie (Other), PharmaMar (Industry)
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100
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Real-world Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Lurbinectedin as Part of the French Early Access Program (ATU).
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. demographic and clinical characteristics of patients [8 months]

    age

  2. demographic and clinical characteristics of patients [8 months]

    sex

  3. demographic and clinical characteristics of patients [8 months]

    clinical stage

  4. demographic and clinical characteristics of patients [8 months]

    prior therapy

Secondary Outcome Measures

  1. Overall Survival (OS) [8 months]

    OS is defined as the time from the first dose of treatment with lurbinectedin to death from any cause

  2. Real-world progression-free survival [8 months]

    time from first dose of treatment with lurbinectedin to first occurrence of disease progression or death from any cause during the study

  3. Best response [8 months]

    best response recorded from the start of treatment with lurbinectedin until disease progression or start of further anti-cancer treatment

  4. Duration of treatment [8 months]

    time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with lurbinectedin

  5. Pattern of tumor progression [8 months]

    site of disease progression after treatment with lurbinectedin

  6. Duration of treatment with lurbinectedin beyond progression [8 months]

    time between first occurrence of disease progression and treatment discontinuation

  7. Adverse Drug Reaction [8 months]

    maximal grade 3-4-5 treatment-related adverse events (SAEs, TRAEs), and immune-related events will be recorded for each patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Curie Paris France
2 Villefranche-Sur-Saône - CH Villefranche-sur-Saône France

Sponsors and Collaborators

  • Intergroupe Francophone de Cancerologie Thoracique
  • Groupe Français de Pneumo-Cancérologie
  • PharmaMar

Investigators

  • Study Chair: Nicolas Girard, Institut Curie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT05285033
Other Study ID Numbers:
  • IFCT-2105
First Posted:
Mar 17, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022