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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03092739
• Collaborator: (none)
• Enrollment: 184
• Locations: 8
• Actual Duration (Months): 13.1
• Patients Per Site: 23
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell	Diagnostic Test: PD-L1 Immunocytochemistry (ICC); Diagnostic Test: PD-L1 Immunohistochemistry (IHC)

Study Design

• Study Type: Observational
• Actual Enrollment: 184 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: May 3, 2017
• Actual Primary Completion Date: Jan 8, 2018
• Actual Study Completion Date: Jun 6, 2018

Arms and Interventions

Arm

Intervention/Treatment

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.

Diagnostic Test: PD-L1 Immunocytochemistry (ICC); PD-L1 expression in the cytological specimens will be assessed using different antibodies.; Diagnostic Test: PD-L1 Immunohistochemistry (IHC); PD-L1 expression in the histological specimens will be assessed using different antibodies.

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci	Praha 2		Czechia	128 08
2	Universitätsklinikum Göttingen, Institut für Pathologie	Göttingen		Germany	37075
3	Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc	Warszawa		Poland	01-138
4	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Anatomía Patológica	A Coruña	LA Coruña	Spain	15006
5	Hospital Universitario La Paz; Servicio de Anatomia Patologica	Madrid		Spain	28046
6	HOSPITAL DE MADRID NORTE SANCHINARRO- C. INTEGRAL ONC. CLARA CAMPAL; Servicio Anatomia Patologica	Madrid		Spain	28050
7	Universitätsspital Basel; Pathologie	Basel		Switzerland	4031
8	Aberdeen Royal Infirmary	Aberdeen		United Kingdom	AB25 2ZN

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03092739
• Other Study ID Numbers: MO29978
• First Posted: Mar 28, 2017
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell

Study Results

No Results Posted as of Jul 23, 2019