RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

Completed

• Conditions: Small-cell Lung Cancer

• Registration Number: NCT05285033
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

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 Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-17
• Study Start: 2022-04-01
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
demographic and clinical characteristics of patients	8 months	prior therapy

Secondary Outcome Measures

Name	Time	Method
Pattern of tumor progression	8 months	site of disease progression after treatment with lurbinectedin
Overall Survival (OS)	8 months	OS is defined as the time from the first dose of treatment with lurbinectedin to death from any cause
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
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
Duration of treatment with lurbinectedin beyond progression	8 months	time between first occurrence of disease progression and treatment discontinuation
Best response	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	8 months	time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with lurbinectedin

Trial Locations

Locations (2)

Villefranche-Sur-Saône - CH; 🇫🇷 Villefranche-sur-Saône, France

Institut Curie; 🇫🇷 Paris, France