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RW Effectiveness of Lurbinectedin in Extensive Stage SCLC (LURBICLIN)

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ClinicalTrials.gov Identifier: NCT05285033
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : August 10, 2022
Sponsor:
Collaborators:
Groupe Français de Pneumo-Cancérologie
PharmaMar
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Tracking Information
First Submitted Date March 4, 2022
First Posted Date March 17, 2022
Last Update Posted Date August 10, 2022
Actual Study Start Date April 1, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2022)
  • demographic and clinical characteristics of patients [ Time Frame: 8 months ]
    age
  • demographic and clinical characteristics of patients [ Time Frame: 8 months ]
    sex
  • demographic and clinical characteristics of patients [ Time Frame: 8 months ]
    clinical stage
  • demographic and clinical characteristics of patients [ Time Frame: 8 months ]
    prior therapy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2022)
  • 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
  • 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
  • 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
  • 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
  • Pattern of tumor progression [ Time Frame: 8 months ]
    site of disease progression after treatment with lurbinectedin
  • Duration of treatment with lurbinectedin beyond progression [ Time Frame: 8 months ]
    time between first occurrence of disease progression and treatment discontinuation
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RW Effectiveness of Lurbinectedin in Extensive Stage SCLC
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).
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Small-cell Lung Cancer
Intervention Drug: Lurbinectedin
Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).
Study Groups/Cohorts Not Provided
Publications * Trigo J, Subbiah V, Besse B, Moreno V, López R, Sala MA, Peters S, Ponce S, Fernández C, Alfaro V, Gómez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martínez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27. Erratum in: Lancet Oncol. 2020 Dec;21(12):e553.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 16, 2022)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Franck Morin 00331.56.81.10.45 contact@ifct.fr
Contact: Pascale Missy 00331.56.81.10.45 contact@ifct.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT05285033
Other Study ID Numbers IFCT-2105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Intergroupe Francophone de Cancerologie Thoracique
Original Responsible Party Same as current
Current Study Sponsor Intergroupe Francophone de Cancerologie Thoracique
Original Study Sponsor Same as current
Collaborators
  • Groupe Français de Pneumo-Cancérologie
  • PharmaMar
Investigators
Study Chair: Nicolas Girard Institut Curie
PRS Account Intergroupe Francophone de Cancerologie Thoracique
Verification Date August 2022