RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

Small-cell Lung Cancer Clinical Trial

— LURBICLIN  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285033
• Other study ID #: IFCT-2105
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2023
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma
• 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).

Locations

Country	Name	City	State
France	Institut Curie	Paris
France	Villefranche-Sur-Saône - CH	Villefranche-sur-Saône

Sponsors (3)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique	Groupe Français de Pneumo-Cancérologie, PharmaMar

Country where clinical trial is conducted

France, 

References & 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. Erratum In: Lancet Oncol. 2020 Dec;21(12):e553. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demographic and clinical characteristics of patients	age	8 months
Primary	demographic and clinical characteristics of patients	sex	8 months
Primary	demographic and clinical characteristics of patients	clinical stage	8 months
Primary	demographic and clinical characteristics of patients	prior therapy	8 months
Secondary	Overall Survival (OS)	OS is defined as the time from the first dose of treatment with lurbinectedin to death from any cause	8 months
Secondary	Real-world progression-free survival	time from first dose of treatment with lurbinectedin to first occurrence of disease progression or death from any cause during the study	8 months
Secondary	Best response	best response recorded from the start of treatment with lurbinectedin until disease progression or start of further anti-cancer treatment	8 months
Secondary	Duration of treatment	time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with lurbinectedin	8 months
Secondary	Pattern of tumor progression	site of disease progression after treatment with lurbinectedin	8 months
Secondary	Duration of treatment with lurbinectedin beyond progression	time between first occurrence of disease progression and treatment discontinuation	8 months
Secondary	Adverse Drug Reaction	maximal grade 3-4-5 treatment-related adverse events (SAEs, TRAEs), and immune-related events will be recorded for each patient	8 months

External Links

•   IFCT website