Small-cell Lung Cancer
Conditions
Keywords
IFCT, Small-cell Lung Cancer, Lurbinectedin, Real-world study
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.
Interventions
DRUGLurbinectedin
Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).
Sponsors
Groupe Francais De Pneumo-Cancerologie
PharmaMar
Intergroupe Francophone de Cancerologie Thoracique
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| demographic and clinical characteristics of patients | 8 months | age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 8 months | OS is defined as the time from the first dose of treatment with lurbinectedin to death from any cause |
| 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 | 8 months | time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with lurbinectedin |
| 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 with lurbinectedin beyond progression | 8 months | time between first occurrence of disease progression and treatment discontinuation |
| 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 |
| Pattern of tumor progression | 8 months | site of disease progression after treatment with lurbinectedin |
Countries
France
Outcome results
None listed