Etude : LIBELULE /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : LIBELULE

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Chimiothérapie / Immunothérapie / Thérapie ciblée

Cadre réglementaire : RIPH2

Dernière MÀJ : 13/01/2022
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III, randomisée, évaluant la faisabilité et la pertinence clinique de la biopsie liquide chez les patients avec suspicion de cancer du poumon métastatique

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Lung cancer is diagnosed at metastatic stage in 60% of the cases. For these patients, first-line treatment is based on histology and molecular characterization of non-squamous non-small cell lung cancer (NSCLC). Thus, quality and quantity of tumor tissue are crucial to determine the appropriate treatment (targeted therapies, chemotherapy and immunotherapy).

However, in routine practice, tissue quality and quantity can be limited (25%), resulting in the need for tumor rebiopsy for molecular analysis. Therefore, lung cancer patients often experience substantial delays before treatment initiation that may be associated with worse patient experience of subsequent cancer care and poorer clinical outcomes.

"Liquid biopsies" (LB) are used to detect genomic alterations in cell-free circulating DNA (cfDNA). Since very recently, they are routinely used in reference centers for the detection of EGFR-mutations when tissue is not sufficient for molecular characterization. Importantly, the feasibility and clinical relevance of systematic liquid biopsies in routine practice has never been evaluated in patients with suspicious advanced lung cancer.

Investigators hypothesize that using systematic LB in patients with clinical suspicion of metastatic lung cancer may reduce time-to-treatment initiation and avoid tissue rebiopsy.

Investigators performed a retrospective study including 250 NSCLC patients treated in a tertiary Cancer Center and in the University Hospital of Lyon, France. The mean time-to-appropriate frontline treatment initiation (TTI) was 42+/-22.5 days. With the use of LB at the time of first consultation, the investigators believe it is possible to reduce the mean TTI down to 33 days (21% reduction in TTI) in the overall population with suspicious metastatic lung cancer, including a 50% and 40% reduction in TTI for EGFR/ALK/ROS1/BRAF V600E subgroups and KRAS/LKB1/ERBB2/c-MET/BRAF non V600E subgroups, respectively.

Investigators therefore designed a "real-life" randomized study to evaluate the feasibility and clinical relevance of LB to decrease the TTI, which may in turn improve patients' outcome. Genomic analyses of circulating cfDNA will be performed using a robust and highly sensitive technology (InVision®), that profiles the presence of genomic aberrations in a panel of 35 genes including mutations, insertion/deletions and rearrangements, including all actionable alterations required to initiate the appropriate first-line therapy (EGFR-, ALK-, ROS1 and BRAF V600E).

2 arms:
- Experimental: Liquid biopsy
Liquid biopsy will be performed at the first visit using InVisionFirst®. Treatment will be determined by (i) genomic characterization in plasma for patients with druggable alteration in first-line, (ii) after pathology results (including assessment of PD-L1 level of expression by immunohistochemistry) for patients with an informative molecular characterization on plasma and no druggable alteration in first-line and (iii) after pathology results and tissue molecular characterization for the remaining patients.
- No Intervention: Cytological or histological sampling
During the first visit, cytological or histological sampling will be planned and treatment will be initiated according to European Society of Medical Oncology (ESMO) recommendations; in case of a tissue sample inadequate for genomic characterization, physicians may resort to liquid biopsy according to their usual practice and available technology.

Phase : III

Stade : Métastatique

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Age ≥ 18 years;
- Patients with clinico-radiological suspicious presentation of stage IV lung cancer;
- No prior chemotherapy for locally advanced or metastatic NSCLC;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Life expectancy > 12 weeks;
- No contraindication to systemic lung cancer treatment;
- No planned or previous inclusion in another 1st line therapy study;
- Covered by a medical insurance;
- Signed informed consent prior to any study-specific procedure;
- No prior biopsy or cytology for lung cancer diagnosis.

Critères de non-inclusion : - Pregnant or breastfeeding women;
- Patient concurrently using other approved or investigational antineoplastic agents;
- Major concurrent disease affecting cardiovascular system, liver, kidneys, hematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;
- Prior history of malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years;
- Patient requiring tutorship or curatorship.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03721120
Promoteur :
Centre Léon Bérard
Type de sponsor : Institutionnel
69373 Lyon cedex 08 - 69373 Lyon cedex 08
69008 LYON 08

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Radj GERVAIS

TEC / ARC / IDE :
Karim HAMOND
k.hamond@
baclesse.unicancer.fr

Statut de l'essai : OUVERT

MAJ : 31/01/2020

Centre investigateur :
ILC Maurice Tubiana - 20 Avenue du Capitaine Guynemer - 14000 CAEN

Investigateur :
Emmanuel SEVIN

TEC / ARC / IDE :
Aline MEZERGUES
guillaume.3c@
gmail.com

Statut de l'essai : OUVERT

MAJ : 22/01/2020

Centre investigateur :
CHP du Cotentin - 46 rue du val de Saire - 50100 CHERBOURG EN COTENTIN

Investigateur :
Laure KALUZINSKI

TEC / ARC / IDE :
Aude GREBERT-MANUARDI
aude.grebertmanuardi@
ch-cotentin.fr

Statut de l'essai : OUVERT

MAJ : 15/10/2019

Centre investigateur :
CH de Bayeux - 13 rue de Nesmond - BP 18127 - 14400 BAYEUX

Investigateur :
Annie PEYTIER

TEC / ARC / IDE :
Pauline RADENAC
pradenac@
onconormandie.fr

Statut de l'essai : OUVERT

MAJ : 05/08/2019

Centre investigateur :
Polyclinique du Parc - 20 Avenue du Capitaine Guynemer - 14000 CAEN

Investigateur :
Emmanuel SEVIN

TEC / ARC / IDE :
Aline MEZERGUES
guillaume.3c@
gmail.com

Statut de l'essai : OUVERT

MAJ : 22/01/2020