Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)
EPNEC
Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)
1 other identifier
observational
86
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2017
CompletedFirst Submitted
Initial submission to the registry
October 4, 2017
CompletedFirst Posted
Study publicly available on registry
October 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedMarch 12, 2020
March 1, 2020
12 months
October 4, 2017
March 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)
Determine the frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)in terms of percentage of tumor cells expressing PD-L1 in immunohistochemistry (IHC) at the time of diagnosis: The frequency of PD-L1 expression determined by IHC will be as follow: * Negative PD-L1 tumours (\<1% of positive tumour cells) * Positive PD-L1 tumours (\> or = to 1% of positive tumour cells) * Low positive PD-L1 tumours (from 1% to 49% of positive tumour cells expressed) * High positive PD-L1 tumours (\> or = 50% of positive tumour cells expressed)
Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Secondary Outcomes (4)
Correlation of PD-L1 expression of tumour cells with clinical data
Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Objective Response Rate (ORR)
Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Progression-free survival (PFS)
Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Overall survival (OS)
Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Interventions
The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.
Eligibility Criteria
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.
You may qualify if:
- Patients aged \> or = 18 years
- Diagnosis of Large-cell NEC confirmed by centralised reading
- Tumoral materials available and readable for PD-L1 labeling
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Centre Hospitalier D Argenteuil
Argenteuil, VAL D'oise, 95100, France
Site 12
Aix-en-Provence, 13100, France
Centre Hospitalier Universitaire
Angers, 49033, France
Site 05
Bastia, 20200, France
Site 22
Beauvais, 60021, France
Centre Hospitalier du Morvan
Brest, 29200, France
Site 43
Caen, 14000, France
Site 48
Clermont-Ferrand, 63000, France
Site 33
Créteil, 94010, France
Site 32
Elbeuf, 76503, France
Site 04
Gap, 05000, France
Centre Hospitalier Les Oudairies
La Roche-sur-Yon, 85000, France
Centre Hospitalier Universitaire DUPUYTREN
Limoges, 87042, France
Hospital du Cluzeau
Limoges, 87042, France
Site 00
Limoges, France
Centre Hospitalier Lyon Sud
Lyon, 69495, France
Site 25
Mantes-la-Jolie, 78200, France
Site 06
Marseille, 13274, France
Site 01
Meaux, 77108, France
Site 42
Orléans, 45032, France
Hospital Saint Antoine
Paris, 75012, France
Site 26
Paris, 75012, France
Site 19
Périgueux, 24019, France
Site 02
Reims, 51092, France
Site 18
Rouen, 76031, France
Site 17
Rouen, 76233, France
Site 14
Toulon, 83800, France
Site 11
Villefranche-sur-Saône, 69655, France
Biospecimen
Slides (tumour materials) at diagnosis
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominque Arpin, MD
Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2017
First Posted
October 9, 2017
Study Start
September 26, 2017
Primary Completion
September 14, 2018
Study Completion
October 30, 2018
Last Updated
March 12, 2020
Record last verified: 2020-03