Evaluation of the Feasibility and Clinical Relevance of Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer (LIBELULE)
Metastatic Lung Cancer
About this trial
This is an interventional diagnostic trial for Metastatic Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 (Appendix 2);
- Life expectancy > 12 weeks;
- No contraindication to systemic lung cancer treatment;
- Covered by a medical insurance;
- Signed informed consent prior to any study-specific procedure;
- No prior biopsy or cytology for lung cancer diagnosis.
Exclusion Criteria:
- 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.
Sites / Locations
- Centre Hospitalier de Bayeux
- Hopital Louis Pradel
- Centre François Baclesse
- Centre Maurice Tubiana
- Infirmerie Protestante
- Centre Hospitalier Public du Cotentin
- CH Les Oudairies
- Hôpital Privé Jean Mermoz
- Centre Leon Berard
- Groupe Hospitalier de la région de Mulhouse et Sud-Alsace
- Centre Hospitalier Annecy Genevois
- Institut de Cancérologie Lucien Neuwirth
- CHRU Saint-Etienne
- Centre Paul Strauss
- Hôpital Nord-Ouest
- Médiôle Lyon-Villeurbanne
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Liquid biopsy
Cytological or histological sampling
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.
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.