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

Completed

• Conditions: Large Cell Lung Cancer; Neuroendocrine Carcinoma of Lung (Diagnosis)

• Registration Number: NCT03305133
• Lead Sponsor: Groupe Francais De Pneumo-Cancerologie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-26
• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-09
• Primary Completion: 2018-09-14
• Study Completion: 2018-10-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (28)

Site 05; 🇫🇷 Bastia, France

Site 43; 🇫🇷 Caen, France

Site 48; 🇫🇷 Clermont Ferrand, France

Site 32; 🇫🇷 Elbeuf, France

Site 22; 🇫🇷 Beauvais, France

Site 19; 🇫🇷 Perigueux, France

Site 02; 🇫🇷 Reims, France

Site 11; 🇫🇷 Villefranche Sur Saone, France

Centre Hospitalier Les Oudairies; 🇫🇷 La Roche Sur Yon, France

Centre Hospitalier Universitaire DUPUYTREN; 🇫🇷 Limoges, France

Site 00; 🇫🇷 Limoges, France

Site 14; 🇫🇷 Toulon, France

Centre Hospitalier D Argenteuil; 🇫🇷 Argenteuil, VAL D'oise, France

Centre Hospitalier du Morvan; 🇫🇷 Brest, France

Site 33; 🇫🇷 Creteil, France

Site 06; 🇫🇷 Marseille, France

Site 42; 🇫🇷 Orleans, France

Site 12; 🇫🇷 Aix En Provence, France

Centre Hospitalier Universitaire; 🇫🇷 Angers, France

Hospital du Cluzeau; 🇫🇷 Limoges, France

Site 25; 🇫🇷 Mantes La Jolie, France

Site 18; 🇫🇷 Rouen, France

Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, France

Hospital Saint Antoine; 🇫🇷 Paris, France

Site 26; 🇫🇷 Paris, France

Site 04; 🇫🇷 GAP, France

Site 01; 🇫🇷 Meaux, France

Site 17; 🇫🇷 Rouen, France