Clinical trial NCT03092739: A Study to Assess Programmed Death Ligand-1 (PD-L1) Expression in Cytological Versus Histological Lung Cancer Specimens
Official title: A Non-Interventional Multinational Study to Assess PD-L1 Expression in Cytological Versus Histological Non-Small Cell or Small Cell Lung Cancer Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 184
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with any stage of NSCLC or SCLC who have cytological and histological samples available.

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).


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: approximately 12 months
measure: 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
timeFrame: approximately 12 months
measure: 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
timeFrame: approximately 12 months
measure: Percentage of Total Immune Cells That Display Discernible PD-L1 Staining of any Intensity in Cytological Samples As Assessed Using PD-L1 ICC Assay
timeFrame: approximately 12 months
measure: 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
timeFrame: approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci
city: Göttingen
country: Germany
facility: Universitätsklinikum Göttingen, Institut für Pathologie
city: Warszawa
country: Poland
facility: Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Anatomía Patológica
state: LA Coruña
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Anatomia Patologica
city: Madrid
country: Spain
facility: HOSPITAL DE MADRID NORTE SANCHINARRO- C. INTEGRAL ONC. CLARA CAMPAL; Servicio Anatomia Patologica
city: Basel
country: Switzerland
facility: Universitätsspital Basel; Pathologie
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: