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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2018-06-06

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PD-L1 Immunocytochemistry (ICC)

Intervention Type DIAGNOSTIC_TEST

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

PD-L1 Immunohistochemistry (IHC)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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PD-L1 Immunocytochemistry (ICC)

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

Intervention Type DIAGNOSTIC_TEST

PD-L1 Immunohistochemistry (IHC)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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