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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03092739
Date of registration:	23/03/2017
Prospective Registration:	Yes
Primary sponsor:	Hoffmann-La Roche
Public title:	A Study to Assess Programmed Death Ligand-1 (PD-L1) Expression in Cytological Versus Histological Lung Cancer Specimens
Scientific title:	A Non-Interventional Multinational Study to Assess PD-L1 Expression in Cytological Versus Histological Non-Small Cell or Small Cell Lung Cancer Specimens
Date of first enrolment:	May 3, 2017
Target sample size:	184
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03092739
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Czech Republic	Czechia	Germany	Poland	Spain	Switzerland	United Kingdom

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

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

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Small Cell

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Diagnostic Test: PD-L1 Immunocytochemistry (ICC)

Diagnostic Test: PD-L1 Immunohistochemistry (IHC)

Primary Outcome(s)

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 [Time Frame: approximately 12 months]

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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: approximately 12 months]

Secondary Outcome(s)

Secondary ID(s)

MO29978

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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