Clinical trial NCT03305133: Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)
Official title: Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Large Cell Lung Cancer
Neuroendocrine Carcinoma of Lung (Diagnosis)
Lead sponsor: Groupe Francais De Pneumo-Cancerologie
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting a large-cell NEC taken in charge by investigational centres between January 1st, 2014 and December 31st, 2016.

Alive patients will be identified during disease follow-up visit as per the local current practice and the study will be then proposed to them at that time.

For died patients, eligible patients will be identified by checking the files present at site by the Principal Investigator.

Brief summary: Observational, multicentre, retrospective study on patients taken care according to the national guidelines. The objective is to define, after the diagnosis confirmation, the frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad prognostic and there is no evidence of treatment for these patients with advanced disease in second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of cancer might have a major therapeutic impact in a close future to access immunotherapies.


Eligibility criteria: Inclusion Criteria:

* Patients aged \> or = 18 years
* Diagnosis of Large-cell NEC confirmed by centralised reading
* Tumoral materials available and readable for PD-L1 labeling

Exclusion Criteria:

* Other type of Lung cancers
* Tumoral material not available or not readable for centralised reading
* Tumoral material not available or not readable for PD-L1 labeling

Primary outcomes:
measure: Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)
timeFrame: Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Secondary outcomes:
measure: Correlation of PD-L1 expression of tumour cells with clinical data
timeFrame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
measure: Objective Response Rate (ORR)
timeFrame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
measure: Progression-free survival (PFS)
timeFrame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
measure: Overall survival (OS)
timeFrame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier D Argenteuil
state: VAL D'oise
city: Aix En Provence
country: France
facility: Site 12
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Bastia
country: France
facility: Site 05
city: Beauvais
country: France
facility: Site 22
city: Brest
country: France
facility: Centre Hospitalier du Morvan
city: Caen
country: France
facility: Site 43
city: Clermont Ferrand
country: France
facility: Site 48
city: Creteil
country: France
facility: Site 33
city: Elbeuf
country: France
facility: Site 32
city: GAP
country: France
facility: Site 04
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Les Oudairies
city: Limoges
country: France
facility: Centre Hospitalier Universitaire DUPUYTREN
city: Limoges
country: France
facility: Hospital du Cluzeau
city: Limoges
country: France
facility: Site 00
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Mantes La Jolie
country: France
facility: Site 25
city: Marseille
country: France
facility: Site 06
city: Meaux
country: France
facility: Site 01
city: Orleans
country: France
facility: Site 42
city: Paris
country: France
facility: Hospital Saint Antoine
city: Paris
country: France
facility: Site 26
city: Perigueux
country: France
facility: Site 19
city: Reims
country: France
facility: Site 02
city: Rouen
country: France
facility: Site 18
city: Rouen
country: France
facility: Site 17
city: Toulon
country: France
facility: Site 14
city: Villefranche Sur Saone
country: France
facility: Site 11
Study officials:
affiliation: Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône
name: Dominque Arpin, MD
role: PRINCIPAL_INVESTIGATOR
References: