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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell
• Interventions: Diagnostic Test: PD-L1 Immunocytochemistry (ICC); Diagnostic Test: PD-L1 Immunohistochemistry (IHC)

• Registration Number: NCT03092739
• Lead Sponsor: Hoffmann-La Roche

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-28
• Study Start: 2017-05-03
• Primary Completion: 2018-01-08
• Study Completion: 2018-06-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cytological and Histological Samples	PD-L1 Immunocytochemistry (ICC)	Cytological and histological specimens that meet the eligibility criteria will be analyzed only from those participants who have consented to biomarker research, according to local regulations and ethical guidelines. Cytological samples may originate from fine needle aspirations. Pleural effusions or bronchial cytology samples (brushings and washings) may be allowed. Histological samples may originate from core needle biopsies, bronchial biopsies (thoracoscopy or mediastinoscopy) or surgical tissue resections.
Cytological and Histological Samples	PD-L1 Immunohistochemistry (IHC)	Cytological and histological specimens that meet the eligibility criteria will be analyzed only from those participants who have consented to biomarker research, according to local regulations and ethical guidelines. Cytological samples may originate from fine needle aspirations. Pleural effusions or bronchial cytology samples (brushings and washings) may be allowed. Histological samples may originate from core needle biopsies, bronchial biopsies (thoracoscopy or mediastinoscopy) or surgical tissue resections.

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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

Trial Locations

Locations (8)

Universitätsspital Basel; Pathologie; 🇨🇭 Basel, Switzerland

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Hospital Universitario La Paz; Servicio de Anatomia Patologica; 🇪🇸 Madrid, Spain

Universitätsklinikum Göttingen, Institut für Pathologie; 🇩🇪 Göttingen, Germany

Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc; 🇵🇱 Warszawa, Poland

HOSPITAL DE MADRID NORTE SANCHINARRO- C. INTEGRAL ONC. CLARA CAMPAL; Servicio Anatomia Patologica; 🇪🇸 Madrid, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Anatomía Patológica; 🇪🇸 A Coruña, LA Coruña, Spain

Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci; 🇨🇿 Praha 2, Czechia