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

Hoffmann-La Roche184 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

184

Conditions

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

Interventions

PD-L1 Immunocytochemistry (ICC)DIAGNOSTIC_TEST

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

PD-L1 Immunohistochemistry (IHC)DIAGNOSTIC_TEST

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (8)

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

Prague, Czechia

Universitätsklinikum Göttingen, Institut für Pathologie

Göttingen, Germany

Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc

Warsaw, Poland

Outcomes

Primary Outcomes

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