Clinical trial · Interventional
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.
NCT02785562CI-TRIAL-00070562EXPLORE-PDL1completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of PDL1 expression | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Assessment of PDL1 expression
- description
- Other : assess clinical and pathological characteristics of PDL1 expression in Non Small Cell Lung Cancer patients.
- interventionNames
- Other: Assessment of PDL1 expression
Primary outcomes (3)
- measure
- description of the PDL1 expression groups as follows : PDL1 negative, PDL1 positive, PDL1 weak, PDL1 strongly positive.
- timeFrame
- 24 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTFong 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 18838703
- RESULTKeir 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 18173375