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出境医 / 临床实验 / Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC)

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

Study Description
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

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 86 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)
Actual Study Start Date : September 26, 2017
Actual Primary Completion Date : September 14, 2018
Actual Study Completion Date : October 30, 2018
Arms and Interventions
Outcome Measures
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

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date October 4, 2017
First Posted Date October 9, 2017
Last Update Posted Date March 12, 2020
Actual Study Start Date September 26, 2017
Actual Primary Completion Date September 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2017) 		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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 4, 2017)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Slides (tumour materials) at diagnosis
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.
Condition
  • Large Cell Lung Cancer
  • Neuroendocrine Carcinoma of Lung (Diagnosis)
Intervention Other: Immunohistochemistry
The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2020) 		86
Original Estimated Enrollment
 (submitted: October 4, 2017) 		150
Actual Study Completion Date October 30, 2018
Actual Primary Completion Date September 14, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03305133
Other Study ID Numbers GFPC 03-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Groupe Francais De Pneumo-Cancerologie
Study Sponsor Groupe Francais De Pneumo-Cancerologie
Collaborators Not Provided
Investigators
Principal Investigator: Dominque Arpin, MD Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône
PRS Account Groupe Francais De Pneumo-Cancerologie
Verification Date March 2020

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