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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03305133
Other study ID # GFPC 03-2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 26, 2017
Est. completion date October 30, 2018

Study information

Verified date March 2020
Source Groupe Francais De Pneumo-Cancerologie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date October 30, 2018
Est. primary completion date September 14, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Site 12 Aix En Provence
France Centre Hospitalier Universitaire Angers
France Centre Hospitalier D Argenteuil Argenteuil VAL D'oise
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 Site 04 GAP
France Centre Hospitalier Les Oudairies La Roche Sur Yon
France Centre Hospitalier Universitaire DUPUYTREN Limoges
France Hospital du Cluzeau Limoges
France Site 00 Limoges
France Centre Hospitalier Lyon Sud Lyon
France Site 25 Mantes La Jolie
France Site 06 Marseille
France Site 01 Meaux
France Site 42 Orleans
France Hospital Saint Antoine Paris
France Site 26 Paris
France Site 19 Perigueux
France Site 02 Reims
France Site 17 Rouen
France Site 18 Rouen
France Site 14 Toulon
France Site 11 Villefranche Sur Saone

Sponsors (1)

Lead Sponsor Collaborator
Groupe Francais De Pneumo-Cancerologie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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