Epidemiologic Multicenter Prospective Study in Advanced NSCLC (Non Small Cell Lung Cancer) Patients With PDL1 (Protein Death Ligand 1) Expression.
NCT ID: NCT02785562
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2016-07-21
2020-04-06
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Assessment of PDL1 expression
Other : assess clinical and pathological characteristics of PDL1 expression in Non Small Cell Lung Cancer patients.
Assessment of PDL1 expression
Intervention : 2 biopsy slides will be analyzed in central laboratory.
Interventions
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Assessment of PDL1 expression
Intervention : 2 biopsy slides will be analyzed in central laboratory.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Groupe Francais De Pneumo-Cancerologie
OTHER
Responsible Party
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Principal Investigators
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Christos CHOUAID, Professor
Role: PRINCIPAL_INVESTIGATOR
FCPC Vice President
Locations
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Centre Hospitalier D Argenteuil
Argenteuil, VAL D'oise, France
Site 12
Aix-en-Provence, , France
Centre Hospitalier Universitaire
Angers, , France
Site 22
Beauvais, , France
Centre Hospitalier du Morvan
Brest, , France
Site 48
Clermont-Ferrand, , France
Site 33
Créteil, , France
Site 04
Gap, , France
Centre Hospitalier Les Oudairies
La Roche-sur-Yon, , France
Centre Hospitalier Universitaire DUPUYTREN
Limoges, , France
Site 19
Périgueux, , France
Site 18
Rouen, , France
Site 11
Villefranche-sur-Saône, , France
Countries
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References
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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.
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.
Study Documents
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Other Identifiers
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GFPC 06-2015
Identifier Type: -
Identifier Source: org_study_id
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