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

Lung Cancer Clinical Trial

— EXPLORE-PDL1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785562
• Other study ID #: GFPC 06-2015
• Status: Completed
• Phase: N/A
• Start date: July 21, 2016
• Est. completion date: April 6, 2020

Study information

• Verified date: October 2023
• Source: Groupe Francais De Pneumo-Cancerologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: April 6, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Assessment of PDL1 expression
Intervention : 2 biopsy slides will be analyzed in central laboratory.

Locations

Country	Name	City	State
France	Site 12	Aix En Provence
France	Centre Hospitalier Universitaire	Angers
France	Centre Hospitalier D Argenteuil	Argenteuil	VAL D'oise
France	Site 22	Beauvais
France	Centre Hospitalier du Morvan	Brest
France	Site 48	Clermont Ferrand
France	Site 33	Creteil
France	Site 04	GAP
France	Centre Hospitalier Les Oudairies	La Roche Sur Yon
France	Centre Hospitalier Universitaire DUPUYTREN	Limoges
France	Site 19	Perigueux
France	Site 18	Rouen
France	Site 11	Villefranche Sur Saone

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Francais De Pneumo-Cancerologie

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 Months
Primary	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.	24 Months
Primary	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.	24 Months
Secondary	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.	24 Months
Secondary	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.	24 Months
Secondary	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.	24 Months
Secondary	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.	24 Months