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

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

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).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell
• Intervention / Treatment: Diagnostic test: PD-L1 Immunocytochemistry (ICC); Diagnostic test: PD-L1 Immunohistochemistry (IHC)

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• Czechia
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci
• Germany
  • Göttingen, Germany, 37075
    • Universitätsklinikum Göttingen, Institut für Pathologie
• Poland
  • Warszawa, Poland, 01-138
    • Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Anatomia Patologica
  • Madrid, Spain, 28050
    • HOSPITAL DE MADRID NORTE SANCHINARRO- C. INTEGRAL ONC. CLARA CAMPAL; Servicio Anatomia Patologica
  • LA Coruña
    • A Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Anatomía Patológica
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel; Pathologie
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with any stage of NSCLC or SCLC who have cytological and histological samples available.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cytological and Histological Samples; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): January 8, 2018
• Study Completion (Actual): June 6, 2018

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Carcinoma, Small Cell
• Other Study ID Numbers: MO29978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No