AzTrials
AzTrials

Small-cell Lung CancerLURBICLINNCT05285033

RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

An observational study of Small-cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
Lurbinectedin
How many people
312 participants
Where
2 sitesFrance
Study dates
1 Apr 2022to 15 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • Patients enrolled in a clinical trial assessing treatment with lurbinectedin

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Institut Curie

    Paris

  • Villefranche-Sur-Saône - CH

    Villefranche-sur-Saône

Other trials in France

About this study

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).

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.

Read the 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.

Being tested
Lurbinectedin
Keywords
IFCT, Small-cell Lung Cancer, Lurbinectedin, Real-world study
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LurbinectedinDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. demographic and clinical characteristics of patients

    age

    Measured: 8 months

  2. demographic and clinical characteristics of patients

    sex

    Measured: 8 months

  3. demographic and clinical characteristics of patients

    clinical stage

    Measured: 8 months

  4. demographic and clinical characteristics of patients

    prior therapy

    Measured: 8 months

Secondary outcomes (7)

  1. Overall Survival (OS)

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

    Measured: 8 months

  2. 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

    Measured: 8 months

  3. Best response

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

    Measured: 8 months

  4. Duration of treatment

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

    Measured: 8 months

  5. Pattern of tumor progression

    site of disease progression after treatment with lurbinectedin

    Measured: 8 months

  6. Duration of treatment with lurbinectedin beyond progression

    time between first occurrence of disease progression and treatment discontinuation

    Measured: 8 months

  7. Adverse Drug Reaction

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

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05285033
Sponsor's protocol ID
IFCT-2105
Acronym
LURBICLIN
Status last verified
Jan 2023
First submitted
4 Mar 2022
Last updated
6 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32224306

Questions about this trial

What is this clinical trial studying?

An observational study of Small-cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

demographic and clinical characteristics of patients (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05285033, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in