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

NCT03092739 | Completed

• 1 other identifier: MO29978
• Study Type: observational
• Target: 184
• Locations: 6 countries
• Sites: 8

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).

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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); Diagnostic Test: PD-L1 Immunohistochemistry (IHC)

Interventions

PD-L1 Immunocytochemistry (ICC) DIAGNOSTIC_TEST

PD-L1 expression in the cytological specimens will be assessed using different antibodies.

Cytological and Histological Samples

PD-L1 Immunohistochemistry (IHC) DIAGNOSTIC_TEST

PD-L1 expression in the histological specimens will be assessed using different antibodies.

Cytological and Histological Samples

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci

Prague, 128 08, Czechia

Location

Universitätsklinikum Göttingen, Institut für Pathologie

Göttingen, 37075, Germany

Location

Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc

Warsaw, 01-138, Poland

Location

Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Anatomía Patológica

A Coruña, LA Coruña, 15006, Spain

Location

Hospital Universitario La Paz; Servicio de Anatomia Patologica

Madrid, 28046, Spain

Location

HOSPITAL DE MADRID NORTE SANCHINARRO- C. INTEGRAL ONC. CLARA CAMPAL; Servicio Anatomia Patologica

Madrid, 28050, Spain

Location

Universitätsspital Basel; Pathologie

Basel, 4031, Switzerland

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin fixed, paraffin embedded tumor tissue; formalin fixed paraffin embedded cytological samples (cell blocks) from the same participant will be retained until end of the study.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 28, 2017
• Study Start: May 3, 2017
• Primary Completion: January 8, 2018
• Study Completion: June 6, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); GB (1); PL (1); CH (1); DE (1); CZ (1)