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Completed

NCT Number: NCT05285033

RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

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.

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Key information

Conditions

Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Curie, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lurbinectedin

Drug

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

Primary outcomes

  1. demographic and clinical characteristics of patients

    Time frame: 8 months

    age

  2. demographic and clinical characteristics of patients

    Time frame: 8 months

    sex

  3. demographic and clinical characteristics of patients

    Time frame: 8 months

    clinical stage

  4. demographic and clinical characteristics of patients

    Time frame: 8 months

    prior therapy

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 8 months

    OS is defined as the time from the first dose of treatment with lurbinectedin to death from any cause

  2. Real-world progression-free survival

    Time frame: 8 months

    time from first dose of treatment with lurbinectedin to first occurrence of disease progression or death from any cause during the study

  3. Best response

    Time frame: 8 months

    best response recorded from the start of treatment with lurbinectedin until disease progression or start of further anti-cancer treatment

  4. Duration of treatment

    Time frame: 8 months

    time from first dose of treatment to discontinuation of treatment (interruption of more than 2 months) with lurbinectedin

  5. Pattern of tumor progression

    Time frame: 8 months

    site of disease progression after treatment with lurbinectedin

  6. Duration of treatment with lurbinectedin beyond progression

    Time frame: 8 months

    time between first occurrence of disease progression and treatment discontinuation

  7. Adverse Drug Reaction

    Time frame: 8 months

    maximal grade 3-4-5 treatment-related adverse events (SAEs, TRAEs), and immune-related events will be recorded for each patient

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Collaborators

  • Groupe Francais De Pneumo-Cancerologie
  • PharmaMar

Registry information

Official study 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).

Acronym: LURBICLIN

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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