Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)
- Conditions
- Large Cell Lung CancerNeuroendocrine Carcinoma of Lung (Diagnosis)
- Registration Number
- NCT03305133
- Lead Sponsor
- Groupe Francais De Pneumo-Cancerologie
- Brief Summary
Observational, multicentre, retrospective study on patients taken care according to the national guidelines. The objective is to define, after the diagnosis confirmation, the frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad prognostic and there is no evidence of treatment for these patients with advanced disease in second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of cancer might have a major therapeutic impact in a close future to access immunotherapies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Patients aged > or = 18 years
- Diagnosis of Large-cell NEC confirmed by centralised reading
- Tumoral materials available and readable for PD-L1 labeling
- Other type of Lung cancers
- Tumoral material not available or not readable for centralised reading
- Tumoral material not available or not readable for PD-L1 labeling
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC) Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 Determine the frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)in terms of percentage of tumor cells expressing PD-L1 in immunohistochemistry (IHC) at the time of diagnosis:
The frequency of PD-L1 expression determined by IHC will be as follow:
* Negative PD-L1 tumours (\<1% of positive tumour cells)
* Positive PD-L1 tumours (\> or = to 1% of positive tumour cells)
* Low positive PD-L1 tumours (from 1% to 49% of positive tumour cells expressed)
* High positive PD-L1 tumours (\> or = 50% of positive tumour cells expressed)
- Secondary Outcome Measures
Name Time Method Correlation of PD-L1 expression of tumour cells with clinical data Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification
Objective Response Rate (ORR) Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) to a first line of treatment using RECIST 1.1 criteria as assessed locally
Progression-free survival (PFS) Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 PFS of the first line of treatment using RECIST 1.1 criteria assessed locally defined as the time from first treatment start to disease progression or death for any cause expressed in months
Overall survival (OS) Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 OS defined as the time from first treatment start to death for any cause expressed in months
Trial Locations
- Locations (28)
Centre Hospitalier D Argenteuil
🇫🇷Argenteuil, VAL D'oise, France
Site 12
🇫🇷Aix En Provence, France
Centre Hospitalier Universitaire
🇫🇷Angers, France
Site 05
🇫🇷Bastia, France
Site 22
🇫🇷Beauvais, France
Centre Hospitalier du Morvan
🇫🇷Brest, France
Site 43
🇫🇷Caen, France
Site 48
🇫🇷Clermont Ferrand, France
Site 33
🇫🇷Creteil, France
Site 32
🇫🇷Elbeuf, France
Scroll for more (18 remaining)Centre Hospitalier D Argenteuil🇫🇷Argenteuil, VAL D'oise, France