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

Roche

Status: Completed

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

Treatments: Diagnostic Test: PD-L1 Immunocytochemistry (ICC); Diagnostic Test: PD-L1 Immunohistochemistry (IHC)

Study type: Observational

Funder types: Industry

Identifiers

NCT03092739

MO29978

Details and patient eligibility

About

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).

Enrollment: 184 patients

Sex: All

Volunteers: No 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

Trial design

184 participants in 1 patient group

Cytological and Histological Samples

Description:

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.

Treatment:

Diagnostic Test: PD-L1 Immunocytochemistry (ICC)

Diagnostic Test: PD-L1 Immunohistochemistry (IHC)