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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03092739

Enrollment

184

Registered

2017-03-28

Start date

2017-05-03

Completion date

2018-06-06

Last updated

2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

DIAGNOSTIC_TESTPD-L1 Immunocytochemistry (ICC)

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

DIAGNOSTIC_TESTPD-L1 Immunohistochemistry (IHC)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Czechia, Germany, Poland, Spain, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026