Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

170

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline

Completed

Started Jul 2016

Typical duration for not_applicable lung-cancer

Geographic Reach

1 country

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

First Submitted

Initial submission to the registry

March 1, 2016

Completed

3 months until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

July 21, 2016

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2020

Completed

Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

3.7 years

First QC Date

March 1, 2016

Last Update Submit

October 16, 2023

Conditions

Lung Cancer

Keywords

PDL1 expression : Protein Death Ligand 1 expression .

Outcome Measures

Primary Outcomes (3)

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
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
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 Outcomes (4)

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

Study Arms (1)

Assessment of PDL1 expression

OTHER

Other : assess clinical and pathological characteristics of PDL1 expression in Non Small Cell Lung Cancer patients.

Other: Assessment of PDL1 expression

Interventions

Assessment of PDL1 expressionOTHER

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

Assessment of PDL1 expression

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
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

You may not qualify if:

Age fewer than 18
Pregnancy
Known immune deficit
PS \> 1
Patient treated with Protein D1/Protein Death Ligang1 (PD1/PDL1) therapy on first line setting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Groupe Francais De Pneumo-Cancerologielead

Study Sites (13)

Centre Hospitalier D Argenteuil

Argenteuil, VAL D'oise, 95100, France

Location

Site 12

Aix-en-Provence, 13100, France

Location

Centre Hospitalier Universitaire

Angers, 49033, France

Location

Site 22

Beauvais, 60021, France

Location

Centre Hospitalier du Morvan

Brest, 29200, France

Location

Site 48

Clermont-Ferrand, 63000, France

Location

Site 33

Créteil, 94010, France

Location

Site 04

Gap, 05000, France

Location

Centre Hospitalier Les Oudairies

La Roche-sur-Yon, 85000, France

Location

Centre Hospitalier Universitaire DUPUYTREN

Limoges, 87042, France

Location

Site 19

Périgueux, 24019, France

Location

Site 18

Rouen, 76031, France

Location

Site 11

Villefranche-sur-Saône, 69655, France

Location

Related 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.
PMID: 18838703RESULT
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.
PMID: 18173375RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Christos CHOUAID, Professor
FCPC Vice President
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

May 30, 2016

Study Start

July 21, 2016

Primary Completion

April 6, 2020

Study Completion

April 6, 2020

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing: Will not share

Locations

FR(13)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (1)

Assessment of PDL1 expression

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Available IPD Datasets

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (1)

Assessment of PDL1 expression

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Available IPD Datasets

Locations