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Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03305133
Recruitment Status : Unknown
Verified October 2017 by Groupe Francais De Pneumo-Cancerologie.
Recruitment status was:  Not yet recruiting
First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Groupe Francais De Pneumo-Cancerologie

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.

Condition or disease Intervention/treatment
Large Cell Lung Cancer Neuroendocrine Carcinoma of Lung (Diagnosis) Other: Immunohistochemistry

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)
Estimated Study Start Date : October 10, 2017
Estimated Primary Completion Date : March 15, 2018
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Immunohistochemistry
    The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.


Primary Outcome Measures :
  1. Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC) [ Time Frame: Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 ]

    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)


Secondary Outcome Measures :
  1. Correlation of PD-L1 expression of tumour cells with clinical data [ Time Frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 ]
    Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification

  2. Objective Response Rate (ORR) [ Time Frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 ]
    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

  3. Progression-free survival (PFS) [ Time Frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 ]
    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

  4. Overall survival (OS) [ Time Frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 ]
    OS defined as the time from first treatment start to death for any cause expressed in months


Biospecimen Retention:   Samples Without DNA
Slides (tumour materials) at diagnosis


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305133


Contacts
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Contact: Dominique Arpin, MD 0033(0)474092723 DArpin@lhopitalnordouest.fr
Contact: Marie Bernardi, MD 0033(0)442335067 mbernard@ch-ax.fr

Locations
Show Show 28 study locations
Sponsors and Collaborators
Groupe Francais De Pneumo-Cancerologie
Investigators
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Principal Investigator: Dominque Arpin, MD Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône

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Responsible Party: Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier: NCT03305133    
Other Study ID Numbers: GFPC 03-2017
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Neuroendocrine
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases