Epidemiologic Multicenter Prospective Study in Advanced NSCLC (Non Small Cell Lung Cancer) Patients With PDL1 (Protein Death Ligand 1) Expression. (EXPLORE-PDL1)

October 16, 2023 updated by: Groupe Francais De Pneumo-Cancerologie

Epidemiologic Multicenter Prospective Study in Advanced NSCLC Patients With PDL1 Expression : Evaluation of Clinical and Pathological Characteristics of PDL1 High Expression Patients Compared to Patients With a Weak or no Expression of PDL1.

Epidemiologic multicenter prospective study in advanced NSCLC patients with PDL1 expression : evaluation of clinical and pathological characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Few data are published on the clinical and pathological characteristics of advanced NSCLC with high PDL1 expression compare to weak and no expression populations.

There is not for the moment a standard test to determine a relevant target population. Preliminary data showed that around 25% of the NSCLC population may have a high PDL1 expression and may have a greater benefit of anti PDL1 therapy. But in fact limited data have been published in European populations on the clinical and pathological characteristics (high PDL1 expression) compared to the weak expression and no expression populations. More over the prognosis rule of a high PDL1 expression in NSCLC is not definitive, with some studies indicating it is a positive prognostic factor while other studies showing that it is a negative prognostic factor.

To understand if there are differences in terms of prognostic between advanced NSCLC with high and low/no expression of PDL1 is a major challenge for the future management strategy of these patients. The results of this study should helps to elaborate new guidelines for this population. Therefore is also important to had data's on the natural course of the disease in these population for building cost effectiveness models of new immune therapies.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

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
      • Beauvais, France, 60021
        • Site 22
      • Brest, France, 29200
        • Centre Hospitalier du Morvan
      • Clermont Ferrand, France, 63000
        • Site 48
      • Creteil, France, 94010
        • Site 33
      • GAP, France, 05000
        • Site 04
      • La Roche Sur Yon, France, 85000
        • Centre Hospitalier Les Oudairies
      • Limoges, France, 87042
        • Centre Hospitalier Universitaire Dupuytren
      • Perigueux, France, 24019
        • Site 19
      • Rouen, France, 76031
        • Site 18
      • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years or more

    • With locally advanced stage (IIIb) to stage IV NSCLC - Non Small Cell Lung Cancer -
    • Histological diagnostic :
  • No known Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) / Reactive Oxygen Species (ROS) translocation

  • At least 2 slides of tumoral sample available

    • No previous chemotherapy treatment. Neo or adjuvant therapy is allowed if done at least one year before inclusion
    • Performance Status ( PS) 0/1

Planned to receive a platin based standard treatment (cisplatin or carboplatin with bevacizumab (restricted to no squamous) pemetrexed(restricted to no squamous) , gemcitabine, vinorelbine, docetaxel or taxol, on first line setting, in standard dose

• A RECIST - Response Evaluation Criteria In Solid Tumor - target lesion

Exclusion Criteria:

  • Age fewer than 18
  • Pregnancy
  • Known immune deficit
  • PS > 1
  • Inclusion in a clinical therapeutic trial in first line
  • Patient treated with Protein D1/Protein Death Ligang1 (PD1/PDL1) therapy on first line setting.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Assessment of PDL1 expression
Other : assess clinical and pathological characteristics of PDL1 expression in Non Small Cell Lung Cancer patients.
Other: Assessment of PDL1 expression
Intervention : 2 biopsy slides will be analyzed in central laboratory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of the PDL1 expression groups as follows : PDL1 negative, PDL1 positive, PDL1 weak, PDL1 strongly positive.
Time Frame: 24 Months

Descriptive and comparative analyses of different sub-populations will be performed with qualitative and quantitative variables. Quantitative variables will be described using the following descriptive statistics: sample size, number of missing values, mean, standard deviation, median, minimum and maximum.

Qualitative variables will be described using the following descriptive statistics: sample size, number of missing values and percentage of each modality calculated from the responses expressed.

The bivariate statistical analyses performed will be subjected to statistical tests, based on the nature of the variables analyzed.
24 Months
Clinical characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.
Time Frame: 24 Months

Descriptive and comparative analyses of different sub-populations will be performed with qualitative and quantitative variables. Quantitative variables will be described using the following descriptive statistics: sample size, number of missing values, mean, standard deviation, median, minimum and maximum.

Qualitative variables will be described using the following descriptive statistics: sample size, number of missing values and percentage of each modality calculated from the responses expressed.

The bivariate statistical analyses performed will be subjected to statistical tests, based on the nature of the variables analyzed.
24 Months
Pathological characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.
Time Frame: 24 Months

Descriptive and comparative analyses of different sub-populations will be performed with qualitative and quantitative variables. Quantitative variables will be described using the following descriptive statistics: sample size, number of missing values, mean, standard deviation, median, minimum and maximum.

Qualitative variables will be described using the following descriptive statistics: sample size, number of missing values and percentage of each modality calculated from the responses expressed.

The bivariate statistical analyses performed will be subjected to statistical tests, based on the nature of the variables analyzed.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical analysis of the patients' outcome : measure of Overall Survival (OS).
Time Frame: 24 Months

Descriptive and comparative analyses of different sub-populations will be performed with qualitative and quantitative variables. Quantitative variables will be described using the following descriptive statistics: sample size, number of missing values, mean, standard deviation, median, minimum and maximum.

Qualitative variables will be described using the following descriptive statistics: sample size, number of missing values and percentage of each modality calculated from the responses expressed.

The bivariate statistical analyses performed will be subjected to statistical tests, based on the nature of the variables analyzed.
24 Months
Immune characteristics of high PDL1 expression, concordance between PDL1 expression and description of immune environment measured through density of the intra tumoral Cluster of differentiation 8+ lymphocyte T cell (CD8+ Tcells/mDC).
Time Frame: 24 Months
The density of tumoral T cells will be described in the overall population and each subgroup through descriptive statistics. The Chi2 test will be used to assess the significance of the difference between the different subgroups.
24 Months
Quality of life of the patients measured at each cycle of therapy thanks to EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D questionnaire).
Time Frame: 24 Months
A descriptive analysis of the answers to the EQ5D will be performed. Evolution of the EQ5D profile will be evaluated. Exploratory analyzes of various risk factors of impaired quality of life will be realized. The proportion of patients reporting "no", "some", or "extreme" EQ5D health state profiles at pre-specified time points will be described.
24 Months
Measure of the Health Care Resource Use (HCRU) associated to the management of the patients thanks to EQ5D (EuroQol Group 5-Dimension Self-ReportQuestionnaire score) questionnaire.
Time Frame: 24 Months
Health Care Resource Use consumption will be measured associated to EQ5D questionnaire answers.
24 Months

Collaborators and Investigators

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

Sponsor

Groupe Francais De Pneumo-Cancerologie

Investigators

  • Principal Investigator: Christos CHOUAID, Professor, FCPC Vice President

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 21, 2016

Primary Completion (Actual)

April 6, 2020

Study Completion (Actual)

April 6, 2020

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimated)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFPC 06-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: The login can be obtained directly on gfpc site.

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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