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

March 11, 2020 updated by: Groupe Francais De Pneumo-Cancerologie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
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
Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
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
Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
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
Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Groupe Francais De Pneumo-Cancerologie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominque Arpin, MD, Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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