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Lung CancerNCT03848052

Evolution of the Therapeutic Care in Lung Cancer in France Since 2015 (ESME LC)

An observational study of Lung Cancer, run by UNICANCER at 21 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This database compiles data from existing data available from patient's electronic medical records (EMR) at the 38 participating hospitals (20 French comprehensive cancer centers and 18 public hospitals). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
How many people
75,000 participants
Where
21 sitesFrance
Study dates
2 Oct 2017to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All consecutive patients treated for lung cancer at one of the 38 French participating sites (Private comprehensive cancer centers and public hospitals).

Who may be able to join

  • Adult (over 18)
  • Treated (with radiotherapy or systemic anti-cancer treatment) for a lung cancer or diagnosed with metastatic lung cancer over the selection period at one of the participating site

Who cannot join

  • None

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lise Bosquet, MsC contact

0033668642660

l-bosquet@unicancer.fr

Mathieu Robain, MD, PhD contact

0033144235553

m-robain@unicancer.fr

21 sites in 1 country

France21 sites, 21 recruiting
  • Institut de Cancérologie de l'Ouest - Paul Papin

    Angers, 49933

    Geneviève PERROCHEAU, +33 2 40 67 99 77, genevieve.perrocheau@ico.unicancer.fr

    Loïc CAMPION, loic.campion@ico.unicancer.fr

    Recruiting
  • Institut Bergonié

    Bordeaux, 33076

    Anne JAFFRE, +33 5 56 33 78 48, a.jaffre@bordeaux.unicancer.fr

    Recruiting
  • Centre François Baclesse

    Caen, 14076

    Anne-Valérie GUIZARD, +33 2 31 45 52 45, av.guizard@baclesse.unicancer.fr

    Recruiting
  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Marie-Ange MOURET-REYNIER, +33 4 73 27 81 37, marie-ange.mouret-reynier@clermont.unicancer.fr

    Recruiting
  • Hôpital Intercommunal de Créteil

    Créteil, 94000

    Christos CHOUAID, +33 1 57 02 20 70, christos.chouaid@chicreteil.fr

    David MAHN, +331 57 02 26 14, David.Manh@chicreteil.fr

    Recruiting
  • Centre Georges-François Leclerc

    Dijon, 21079

    Sandrine DABAYUKO, 0033 3 45 34 80 67, sdabakuyo@cgfl.fr

    Recruiting
  • Centre Oscar Lambret

    Lille, 59020

    Marie-Paule LEBITASY, 0033 3 20 29 55 60, m-lebitasy@o-lambret.fr

    Recruiting
  • Centre Léon Bérard

    Lyon, 69373

    Thomas BACHELOT, +33 4 78 78 26 54, thomas.bachelot@lyon.unicancer.fr

    Recruiting
  • Institut Paoli-Calmettes

    Marseille, 13273

    Lilian LABORDE, +33 4 91 22 35 10, LABORDEL@ipc.unicancer.fr

    Recruiting
  • Institut régional du Cancer Montpellier / Val d'Aurelle

    Montpellier, 34298

    Stéphanie DELAINE, +33 4 67 61 47 39, stephaine.delaine@icm.unicancer.fr

    Recruiting
  • Groupe Hospitalier Région Mulhouse et Sud Alsace - Hôpital Emile Muller

    Mulhouse, 68070

    Didier DEBIEUVRE, +33 3 89 64 73 96, debieuvred@ch-mulhouse.fr

    Arnaud MULHOUSE, +33 3 89 64 67 53, etiennea@ghrmsa.fr

    Recruiting
  • Institut de cancérologie de l'Ouest - René Gauducheau

    Nantes, 44805

    Geneviève PERROCHEAU, +33 2 40 67 99 77, genevieve.perrocheau@ico.unicancer.fr

    Loïc CAMPION, loic.campion@ico.unicancer.fr

    Recruiting
  • Centre Antoine Lacassagne

    Nice, 06189

    Emmanuel CHAMOREY, +33 4 92 03 15 29, emmanuel.chamorey@nice.unicancer.fr

    Recruiting
  • Institut Curie

    Paris, 75005

    Etienne BRAIN, 0033144324685, etienne.brain@curie.fr

    Recruiting
  • Institut Jean Godinot

    Reims, 51056

    Damien PARENT, +33 3 26 50 42 76, damien.parent@reims.unicancer.fr

    Recruiting
  • Centre Henri Becquerel

    Rouen, 76038

    Agnès LOEB, +33 2 32 08 22 80, agnes.loeb@chb.unicancer.fr

    Recruiting
  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, 92210

    Etienne BRAIN, +33 1 47 11 15 15, etienne.brain@curie.fr

    Recruiting
  • Centre Paul Strauss

    Strasbourg, 67065

    Michel VELTEN, +33 3 88 25 24 53, mvelten@strasbourg.unicancer.fr

    Recruiting
  • Institut Claudius Regaud

    Toulouse, 31059

    Delphine BERCHERY, 05 31 15 50 60, Berchery.Delphine@iuct-oncopole.fr

    Recruiting
  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Carine LAURENT, +33 3 83 59 83 32, c.laurent@nancy.unicancer.fr

    Recruiting
  • Institut Gustave Roussy

    Villejuif, 94805

    Valérie DEJEAN, +33 1 42 11 46 49, valerie.dejean@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Lung Cancer in France Since 2015

This database compiles data from existing data available from patient's electronic medical records (EMR) at the 38 participating hospitals (20 French comprehensive cancer centers and 18 public hospitals).

Read the detailed description

The database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool.

Data imported into the final database are controlled, recoded, and harmonized before import according to the data management plan. All coding procedures are predefined by the data manager. There is no transmission of individual data; all data are centralized within each center using a shared anonymous format. All data is exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients.

ESME LC Data Platform aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating sites.

Data do not contain any personal data on patients. In compliance with the authorization delivered by the French Data Protection agency to Unicancer, only aggregated statistical reports and publication are released.

Conditions
Lung Cancer
Keywords
lung cancer, observational study, survival, real world data, real life setting
Medical subject headings
Lung Neoplasms

What is being measured

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

  1. Patient characteristics

    Age in years, Tobacco consumption, other exposures, Legal recognition as occupational disease, Medical history, History of other cancer, weight in kg and performance status (ECOG)

    Measured: Baseline

  2. Tumor characteristics

    Staging, Tumor size, sampling Method, histological type

    Measured: Baseline

  3. Treatment patterns

    Drug, therapeutic class, treatment duration at each n treatment line

    Measured: From Baseline until 2024 (yearly basis)

Secondary outcomes (2)
  1. Median overall survival

    Assessment of overall survival through treatment lines

    Measured: From date of diagnosis or first treatment until the date of death from any cause. Follow up until 2024

  2. Median surrogate endpoints for overall survival

    Surrogate endpoints (Progression-free Survival, Time to Progression, Time to Next Treatment) at each n treatment line.

    Measured: From start date of the nth treatment line until the date of first applicable event. Follow up until 2024

Timeline

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

  1. First posted20 Feb 2019
  2. Study start2 Oct 2017
  3. Primary completion24 Oct 2025
  4. Study completion31 Dec 2026 (estimated)

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
75,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03848052
Sponsor's protocol ID
ESME LC
Status last verified
May 2026
First submitted
25 Jan 2018
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Robain M, Pérol M, Girard N, Debieuvre D, Coudert B, Madroszyk A, et al. Programme épidémio-stratégie médicoéconomique : une base nationale de données de vie réelle pour mieux comprendre la prise en charge du cancer bronchopulmonaire en France. Revue des Maladies Respiratoires. 2018 Jan;35:A106.

  • Girard, N., M. Pérol, G. Simon, C. Audigier Valette, R. Gervais, D. Debieuvre, R. Schott, et al. " 90P - Real-world treatment patterns, clinical practice and outcomes for locally advanced, non resectable, non-small cell lung cancer from the French ESME Lung database ". Abstract Book of the European Lung Cancer Congress (ELCC) 10-13 April 2019, Geneva, Switzerland 30 (1 avril 2019): ii34. https://doi.org/10.1093/annonc/mdz067.006.

  • Chouaid C, Filleron T, Debieuvre D, Perol M, Girard N, Dansin E, Lena H, Gervais R, Cousin S, Otto J, Schott R, Planchard D, Madroszyk A, Kaderbhai C, Dubray-Longeras P, Hiret S, Pichon E, Clement-Duchene C, Chenuc G, Simon G, Bosquet L, QUantin X. A Real-World Study of Patients with Advanced Non-squamous Non-small Cell Lung Cancer with EGFR Exon 20 Insertion: Clinical Characteristics and Outcomes. Target Oncol. 2021 Nov;16(6):801-811. doi: 10.1007/s11523-021-00848-9. Epub 2021 Oct 18.

    PubMed 34661827
  • Lamy T, Cabarrou B, Planchard D, Quantin X, Schneider S, Bringuier M, Besse B, Girard N, Chouaid C, Filleron T, Simon G, Baldini C. Biomarker Testing in Older Patients Treated for an Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer: The French ESME Real-Life Multicenter Cohort Experience. Cancers (Basel). 2021 Dec 24;14(1):92. doi: 10.3390/cancers14010092.

    PubMed 35008257
  • Griesinger F, Perol M, Girard N, Durand-Zaleski I, Zacharias S, Bosquet L, Janicke M, Quantin X, Groth A, Fleitz A, Calleja A, Patel S, Lacoin L, Daumont MJ, Penrod JR, Carroll R, Waldenberger D, Reynaud D, Thomas M, Chouaid C. Impact of immune checkpoint inhibitors on the management of locally advanced or metastatic non-small cell lung cancer in real-life practice in patients initiating treatment between 2015 and 2018 in France and Germany. Lung Cancer. 2022 Oct;172:65-74. doi: 10.1016/j.lungcan.2022.08.001. Epub 2022 Aug 6.

    PubMed 36007281
  • Chouaid C, Thomas M, Debieuvre D, Durand-Zaleski I, Zacharias S, Bosquet L, Groth A, Fleitz A, Calleja A, Patel S, Lacoin L, Daumont MJ, Penrod JR, Carroll R, Waldenberger D, Cotte FE, Audigier-Valette C, Griesinger F. Effectiveness of Nivolumab in Second-Line and Later in Patients with Advanced Non-Small Cell Lung Cancer in Real-Life Practice in France and Germany: Analysis of the ESME-AMLC and CRISP Cohorts. Cancers (Basel). 2022 Dec 13;14(24):6148. doi: 10.3390/cancers14246148.

    PubMed 36551632
  • Bringuier M, Carton M, Debieuvre D, Pasquier D, Perol M, Filleron T, Lena H, Quantin X, Simon G, Baldini C. Enrolment of older adults with advanced or metastatic non-small cell lung cancer in first-line clinical trials in the multicentre ESME cohort. J Geriatr Oncol. 2023 Mar;14(2):101423. doi: 10.1016/j.jgo.2022.101423. Epub 2023 Jan 17.

    PubMed 36657245
  • Chouaid C, Bosquet L, Girard N, Kron A, Scheffler M, Griesinger F, Sebastian M, Trigo J, Viteri S, Knott C, Rodrigues B, Rahhali N, Cabrieto J, Diels J, Perualila NJ, Schioppa CA, Sermon J, Toueg R, Erdmann N, Mielke J, Nematian-Samani M, Martin-Fernandez C, Pfaira I, Li T, Mahadevia P, Wolf J. An Adjusted Treatment Comparison Comparing Amivantamab Versus Real-World Clinical Practice in Europe and the United States for Patients with Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Exon 20 Insertion Mutations. Adv Ther. 2023 Mar;40(3):1187-1203. doi: 10.1007/s12325-022-02408-7. Epub 2023 Jan 18.

    PubMed 36652175
  • Belaroussi Y, Bouteiller F, Bellera C, Pasquier D, Perol M, Debieuvre D, Filleron T, Girard N, Schott R, Mathoulin-Pelissier S, Martin AL, Cousin S. Survival outcomes of patients with metastatic non-small cell lung cancer receiving chemotherapy or immunotherapy as first-line in a real-life setting. Sci Rep. 2023 Jun 13;13(1):9584. doi: 10.1038/s41598-023-36623-1.

    PubMed 37311845
  • Valette CA, Filleron T, Debieuvre D, Lena H, Perol M, Chouaid C, Simon G, Quantin X, Girard N. Treatment patterns and clinical outcomes of extensive stage small cell lung cancer (SCLC) in the real-world evidence ESME cohort before the era of immunotherapy. Respir Med Res. 2023 Nov;84:101012. doi: 10.1016/j.resmer.2023.101012. Epub 2023 Mar 27.

    PubMed 37307617
  • Heudel PE, de Montfort A, Debieuvre D, Chouaid C, Carton M, Audigier-Valette C, Filleron T, Chabaud S, Stancu A, Quantin X, Hiret S, Bosquet L, Blay JY. Reduced risk of secondary primary extra pulmonary cancer in advanced/metastatic lung cancer patients treated with immune checkpoint inhibitors. Lung Cancer. 2023 Aug;182:107280. doi: 10.1016/j.lungcan.2023.107280. Epub 2023 Jun 16.

    PubMed 37339550
  • Thomas QD, Quantin X, Lemercier P, Chouaid C, Schneider S, Filleron T, Remon-Masip J, Perol M, Debieuvre D, Audigier-Valette C, Justeau G, Loeb A, Hiret S, Clement-Duchene C, Dansin E, Stancu A, Pichon E, Bosquet L, Girard N, Du Rusquec P. Clinical characteristic and survival outcomes of patients with advanced NSCLC according to KRAS mutational status in the French real-life ESME cohort. ESMO Open. 2024 Jun;9(6):103473. doi: 10.1016/j.esmoop.2024.103473. Epub 2024 Jun 3.

    PubMed 38833966
  • Cabart M, Mourey L, Pasquier D, Schneider S, Lena H, Girard N, Chouaid C, Schott R, Hiret S, Debieuvre D, Quantin X, Madroszyk A, Dubray-Longeras P, Pichon E, Baranzelli A, Justeau G, Perol M, Bosquet L, Cabarrou B. Real-world overview of therapeutic strategies and prognosis of older patients with advanced or metastatic non-small cell lung cancer from the ESME database. J Geriatr Oncol. 2024 Sep;15(7):101819. doi: 10.1016/j.jgo.2024.101819. Epub 2024 Jul 26.

    PubMed 39068144
  • Thomas QD, Girard N, Bosquet L, Cavaillon S, Filleron T, Eltaief S, Chouaid C, Lena H, Debieuvre D, Perol M, Quantin X. Optimizing Treatment Strategies for Egfr-Mutated Non-Small-Cell Lung Cancer Treated with Osimertinib: Real-World Outcomes and Insights. Cancers (Basel). 2024 Oct 23;16(21):3563. doi: 10.3390/cancers16213563.

    PubMed 39518004
  • Justeau G, Chouaid C, Debieuvre D, Audigier-Valette C, Quantin X, Lena H, Bosquet L, Girard N, Schoemaker MJ, Mella M, Pinto Correia B, Rault C, Daumont MJ, Penrod JR, Lee A, Perol M. Real-world treatment and retreatment patterns and outcomes in patients with advanced or metastatic non-small cell lung cancer following nivolumab monotherapy in second line or later in France: an I-O Optimise analysis. Front Oncol. 2025 Feb 20;15:1526931. doi: 10.3389/fonc.2025.1526931. eCollection 2025.

    PubMed 40052124

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by UNICANCER at 21 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 2 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: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Lise Bosquet, MsC (0033668642660, l-bosquet@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient characteristics (time frame: Baseline). The study lists 3 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 NCT03848052, which also lists 19 linked publications.

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 27 May 2026.

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