An observational study in Large Cell Lung Cancer and Neuroendocrine Carcinoma of Lung (Diagnosis), sponsored by Groupe Francais De Pneumo-Cancerologie. Completed at 28 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by Groupe Francais De Pneumo-Cancerologie · Observational
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.
Patients presenting a large-cell NEC taken in charge by investigational centres between January 1st, 2014 and December 31st, 2016.
Alive patients will be identified during disease follow-up visit as per the local current practice and the study will be then proposed to them at that time.
For died patients, eligible patients will be identified by checking the files present at site by the Principal Investigator.
Exclusion Criteria:
The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.
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)
Time frame: Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Groupe Francais De Pneumo-Cancerologie