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

• 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

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (8)

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

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

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

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

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

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

Universitätsspital Basel; Pathologie; 🇨🇭 Basel, Switzerland

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom