Clinical trial NCT05285033: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small-cell Lung Cancer
Keywords: IFCT
Small-cell Lung Cancer
Lurbinectedin
Real-world study
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: Groupe Francais De Pneumo-Cancerologie
name: PharmaMar
First posted: 2022-03-17
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

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

Primary outcomes:
measure: demographic and clinical characteristics of patients
timeFrame: 8 months
measure: demographic and clinical characteristics of patients
timeFrame: 8 months
measure: demographic and clinical characteristics of patients
timeFrame: 8 months
measure: demographic and clinical characteristics of patients
timeFrame: 8 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 8 months
measure: Real-world progression-free survival
timeFrame: 8 months
measure: Best response
timeFrame: 8 months
measure: Duration of treatment
timeFrame: 8 months
measure: Pattern of tumor progression
timeFrame: 8 months
measure: Duration of treatment with lurbinectedin beyond progression
timeFrame: 8 months
measure: Adverse Drug Reaction
timeFrame: 8 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Villefranche-sur-Saône
country: France
facility: Villefranche-Sur-Saône - CH
Study officials:
affiliation: Institut Curie
name: Nicolas Girard
role: STUDY_CHAIR
References:
citation: 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.