Large Cell Lung Cancer, Neuroendocrine Carcinoma of Lung (Diagnosis)
Conditions
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.
Interventions
OTHERImmunohistochemistry
The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.
Sponsors
Groupe Francais De Pneumo-Cancerologie
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed