RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

NCT ID: NCT05285033

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-15

Brief Summary

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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

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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.

Conditions

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Small-cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Lurbinectedin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Francais De Pneumo-Cancerologie

OTHER

Sponsor Role collaborator

PharmaMar

INDUSTRY

Sponsor Role collaborator

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Girard

Role: STUDY_CHAIR

Institut Curie

Locations

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Institut Curie

Paris, , France

Site Status

Villefranche-Sur-Saône - CH

Villefranche-sur-Saône, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 32224306 (View on PubMed)

Related Links

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Other Identifiers

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IFCT-2105

Identifier Type: -

Identifier Source: org_study_id

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