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

Large Cell Lung Cancer Clinical Trial

— EPNEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305133
• Other study ID #: GFPC 03-2017
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Large Cell Lung Cancer
• Lung Neoplasms
• Neuroendocrine Carcinoma of Lung (Diagnosis)

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