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

CompletedN/A

Sponsor: Hoffmann-La Roche

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

Interventions: PD-L1 Immunocytochemistry (ICC), PD-L1 Immunohistochemistry (IHC)

Countries: Czechia, Germany, Poland, Spain, Switzerland, United Kingdom

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 overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (8)

Prague, Czechia
Göttingen, Germany
Warsaw, Poland
A Coruña, LA Coruña, Spain
Madrid, Spain
Madrid, Spain
Basel, Switzerland
Aberdeen, United Kingdom