Clinical trial NCT02785562: Epidemiologic Multicenter Prospective Study in Advanced NSCLC (Non Small Cell Lung Cancer) Patients With PDL1 (Protein Death Ligand 1) Expression.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: PDL1 expression : Protein Death Ligand 1 expression .
Lead sponsor: Groupe Francais De Pneumo-Cancerologie
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: description of the PDL1 expression groups as follows : PDL1 negative, PDL1 positive, PDL1 weak, PDL1 strongly positive.
timeFrame: 24 Months
measure: Clinical characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.
timeFrame: 24 Months
measure: Pathological characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.
timeFrame: 24 Months
Secondary outcomes:
measure: Clinical analysis of the patients' outcome : measure of Overall Survival (OS).
timeFrame: 24 Months
measure: 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).
timeFrame: 24 Months
measure: Quality of life of the patients measured at each cycle of therapy thanks to EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D questionnaire).
timeFrame: 24 Months
measure: 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.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier D Argenteuil
state: VAL D'oise
city: Aix En Provence
country: France
facility: Site 12
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Beauvais
country: France
facility: Site 22
city: Brest
country: France
facility: Centre Hospitalier du Morvan
city: Clermont Ferrand
country: France
facility: Site 48
city: Creteil
country: France
facility: Site 33
city: GAP
country: France
facility: Site 04
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Les Oudairies
city: Limoges
country: France
facility: Centre Hospitalier Universitaire DUPUYTREN
city: Perigueux
country: France
facility: Site 19
city: Rouen
country: France
facility: Site 18
city: Villefranche Sur Saone
country: France
facility: Site 11
Study officials:
affiliation: FCPC Vice President
name: Christos CHOUAID, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.