NCT05285033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

March 4, 2022

Last Update Submit

January 5, 2023

Conditions

Small-cell Lung Cancer

Keywords

IFCTSmall-cell Lung CancerLurbinectedinReal-world study

Outcome Measures

Primary Outcomes (4)

  • demographic and clinical characteristics of patients

    age

    8 months

  • demographic and clinical characteristics of patients

    sex

    8 months

  • demographic and clinical characteristics of patients

    clinical stage

    8 months

  • demographic and clinical characteristics of patients

    prior therapy

    8 months

Secondary Outcomes (7)

  • Overall Survival (OS)

    8 months

  • Real-world progression-free survival

    8 months

  • Best response

    8 months

  • Duration of treatment

    8 months

  • Pattern of tumor progression

    8 months

  • +2 more secondary outcomes

Interventions

LurbinectedinDRUG

Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • Patients enrolled in a clinical trial assessing treatment with lurbinectedin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Curie

Paris, France

Location

Villefranche-Sur-Saône - CH

Villefranche-sur-Saône, France

Location

Related Publications (1)

  • Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez 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.

    PMID: 32224306BACKGROUND

Related Links

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PM 01183

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nicolas Girard

    Institut Curie

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 17, 2022

Study Start

April 1, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)