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Lung CancerEXPLORE-PDL1NCT02785562

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

A study testing Assessment of PDL1 expression in people with Lung Cancer, run by Groupe Francais De Pneumo-Cancerologie at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Assessment of PDL1 expression
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
13 sitesFrance
Study dates
21 Jul 2016to 6 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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
  • Patient treated with Protein D1/Protein Death Ligang1 (PD1/PDL1) therapy on first line setting.

Who cannot join

  • Age fewer than 18
  • Pregnancy
  • Known immune deficit
  • PS > 1

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • Site 12

    Aix-en-Provence, 13100

  • Centre Hospitalier Universitaire

    Angers, 49033

  • Centre Hospitalier D Argenteuil

    Argenteuil, VAL D'oise, 95100

  • Site 22

    Beauvais, 60021

  • Centre Hospitalier du Morvan

    Brest, 29200

  • Site 48

    Clermont-Ferrand, 63000

  • Site 33

    Créteil, 94010

  • Site 04

    Gap, 05000

  • Centre Hospitalier Les Oudairies

    La Roche-sur-Yon, 85000

  • Centre Hospitalier Universitaire DUPUYTREN

    Limoges, 87042

  • Site 19

    Périgueux, 24019

  • Site 18

    Rouen, 76031

  • Site 11

    Villefranche-sur-Saône, 69655

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Lung Cancer
Being tested
Assessment of PDL1 expression
Keywords
PDL1 expression : Protein Death Ligand 1 expression .
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of PDL1 expressionOther

    Intervention : 2 biopsy slides will be analyzed in central laboratory.

Study groups in NCT02785562
Study groupRoleWhat they receive
Assessment of PDL1 expressionOtherOther : assess clinical and pathological characteristics of PDL1 expression in Non Small Cell Lung Cancer patients.
Receives: Other: Assessment of PDL1 expression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. description of the PDL1 expression groups as follows : PDL1 negative, PDL1 positive, PDL1 weak, PDL1 strongly positive.

    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.

    Measured: 24 Months

  2. Clinical characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.

    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.

    Measured: 24 Months

  3. Pathological characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.

    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.

    Measured: 24 Months

Secondary outcomes (4)

  1. Clinical analysis of the patients' outcome : measure of Overall Survival (OS).

    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.

    Measured: 24 Months

  2. 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).

    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.

    Measured: 24 Months

  3. Quality of life of the patients measured at each cycle of therapy thanks to EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D questionnaire).

    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.

    Measured: 24 Months

  4. 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.

    Health Care Resource Use consumption will be measured associated to EQ5D questionnaire answers.

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2016 (estimated)
  2. Study start21 Jul 2016
  3. Primary completion6 Apr 2020
  4. Study completion6 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02785562
Sponsor's protocol ID
GFPC 06-2015
Acronym
EXPLORE-PDL1
Status last verified
Oct 2023
First submitted
1 Mar 2016
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Fong L, Small EJ. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J Clin Oncol. 2008 Nov 10;26(32):5275-83. doi: 10.1200/JCO.2008.17.8954. Epub 2008 Oct 6.

    PubMed 18838703

  • Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26:677-704. doi: 10.1146/annurev.immunol.26.021607.090331.

    PubMed 18173375

Questions about this trial

What is this clinical trial studying?

A study testing Assessment of PDL1 expression in people with Lung Cancer, run by Groupe Francais De Pneumo-Cancerologie at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

description of the PDL1 expression groups as follows : PDL1 negative, PDL1 positive, PDL1 weak, PDL1 strongly positive. (time frame: 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02785562, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.

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