A Study to Assess Programmed Death Ligand-1 (PD-L1) Expression in Cytological Versus Histological Lung Cancer Specimens

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Non-Interventional Multinational Study to Assess PD-L1 Expression in Cytological Versus Histological Non-Small Cell or Small Cell Lung Cancer Specimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092739
• Other study ID #: MO29978
• Status: Completed
• Start date: May 3, 2017
• Est. completion date: June 6, 2018

Study information

• Verified date: July 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of this non-interventional, multinational study is to assess the feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for histological samples obtained from participants with any stage of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 6, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Samples must have been collected in a manner that is compliant with local ethics committee guidance

• Samples must originate from participants diagnosed with NSCLC or SCLC

• Participants must have a pair of at least one cytological and one histological specimen that: Both originate from inside the thorax or from the same ex-thoracic site; Are confirmed to have been collected within a window no more than 6 weeks apart from each other; and are in compliance with the protocol defined sample requirements for histological and cytological specimens

Exclusion Criteria:

• Immune checkpoint inhibitor therapy from 4 weeks prior to collection of the first tumor sample until collection of the second matched sample

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Small Cell

Intervention

Diagnostic Test:
• PD-L1 Immunocytochemistry (ICC)
PD-L1 expression in the cytological specimens will be assessed using different antibodies.
• PD-L1 Immunohistochemistry (IHC)
PD-L1 expression in the histological specimens will be assessed using different antibodies.

Locations

Country	Name	City	State
Czechia	Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci	Praha 2
Germany	Universitätsklinikum Göttingen, Institut für Pathologie	Göttingen
Poland	Instytut Gruzlicy i Chorób Pluc, I Klinika Chorób Pluc	Warszawa
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Anatomía Patológica	A Coruña	LA Coruña
Spain	HOSPITAL DE MADRID NORTE SANCHINARRO- C. INTEGRAL ONC. CLARA CAMPAL; Servicio Anatomia Patologica	Madrid
Spain	Hospital Universitario La Paz; Servicio de Anatomia Patologica	Madrid
Switzerland	Universitätsspital Basel; Pathologie	Basel
United Kingdom	Aberdeen Royal Infirmary	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Czechia,  Germany,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Total Tumor Cells (TC) That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay		approximately 12 months
Primary	Percentage of Total TC Within ten High-Power Fields (HPF) That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay		approximately 12 months
Primary	Percentage of Total Tumor Area That Contain Tumor-Infiltrating Immune Cells of any Discernible PD-L1 Staining of any Intensity in Histological Samples As Assessed Using PD-L1 IHC Assay		approximately 12 months
Primary	Percentage of Total Immune Cells That Display Discernible PD-L1 Staining of any Intensity in Cytological Samples As Assessed Using PD-L1 ICC Assay		approximately 12 months
Primary	Percentage of Total Immune Cells Within ten HPF That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay		approximately 12 months