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)

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.

Study Overview

• Status: Completed
• Conditions: Large Cell Lung Cancer; Neuroendocrine Carcinoma of Lung (Diagnosis)
• Intervention / Treatment: Other: Immunohistochemistry

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• France
  • Aix En Provence, France, 13100
    • Site 12
  • Angers, France, 49033
    • Centre Hospitalier Universitaire
  • Bastia, France, 20200
    • Site 05
  • Beauvais, France, 60021
    • Site 22
  • Brest, France, 29200
    • Centre Hospitalier du Morvan
  • Caen, France, 14000
    • Site 43
  • Clermont Ferrand, France, 63000
    • Site 48
  • Creteil, France, 94010
    • Site 33
  • Elbeuf, France, 76503
    • Site 32
  • GAP, France, 05000
    • Site 04
  • La Roche Sur Yon, France, 85000
    • Centre Hospitalier Les Oudairies
  • Limoges, France, 87042
    • Hospital du Cluzeau
  • Limoges, France, 87042
    • Centre Hospitalier Universitaire Dupuytren
  • Limoges, France
    • Site 00
  • Lyon, France, 69495
    • Centre Hospitalier LYON SUD
  • Mantes La Jolie, France, 78200
    • Site 25
  • Marseille, France, 13274
    • Site 06
  • Meaux, France, 77108
    • Site 01
  • Orleans, France, 45032
    • Site 42
  • Paris, France, 75012
    • Hospital Saint Antoine
  • Paris, France, 75012
    • Site 26
  • Perigueux, France, 24019
    • Site 19
  • Reims, France, 51092
    • Site 02
  • Rouen, France, 76031
    • Site 18
  • Rouen, France, 76233
    • Site 17
  • Toulon, France, 83800
    • Site 14
  • Villefranche Sur Saone, France, 69655
    • Site 11
  • VAL D'oise
    • Argenteuil, VAL D'oise, France, 95100
      • Centre Hospitalier D Argenteuil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of PD-L1 expression of tumour cells with clinical data	Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification	Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Objective Response Rate (ORR)	Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) to a first line of treatment using RECIST 1.1 criteria as assessed locally	Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Progression-free survival (PFS)	PFS of the first line of treatment using RECIST 1.1 criteria assessed locally defined as the time from first treatment start to disease progression or death for any cause expressed in months	Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Overall survival (OS)	OS defined as the time from first treatment start to death for any cause expressed in months	Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016

Collaborators and Investigators

• Sponsor: Groupe Francais De Pneumo-Cancerologie
• Investigators: Principal Investigator: Dominque Arpin, MD, Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 26, 2017
• Primary Completion (ACTUAL): September 14, 2018
• Study Completion (ACTUAL): October 30, 2018

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (ACTUAL): October 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Lung Neoplasms; Carcinoma; Carcinoma, Neuroendocrine
• Other Study ID Numbers: GFPC 03-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No