Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)

Conditions
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Neuroendocrine Carcinoma of Lung (Diagnosis), Large Cell Lung Cancer

Intervention / Treatment
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* Other: Immunohistochemistry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged > or = 18 years Diagnosis of Large-cell NEC confirmed by centralised reading Tumoral materials available and readable for PD-L1 labeling Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Immunohistochemistry|The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC) | 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) | Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of PD-L1 expression of tumour cells with clinical data | Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification | Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 | 
| Objective Response Rate (ORR) | 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 | Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 | 
| Progression-free survival (PFS) | 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 | Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 | 
| Overall survival (OS) | OS defined as the time from first treatment start to death for any cause expressed in months | Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 |