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NCT Number: NCT02785562

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier D Argenteuil, Argenteuil, VAL D'oise, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment of PDL1 expression

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  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).

    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.

  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).

    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.

  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.

    Time frame: 24 Months

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

Sponsors and collaborators

Lead sponsor

Groupe Francais De Pneumo-Cancerologie

Other

Registry information

Official study 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.

Acronym: EXPLORE-PDL1

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 30, 2016
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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