Prognostic Value of PD-L1 in NSCLC

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT03078959
• Lead Sponsor: Fondazione Ricerca Traslazionale

Brief Summary

This is an observational retrospective study. The primary objective is to investigate the expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor samples from 350 patients with early stage treatment-naive non-small-cell lung cancer (NSCLC).

Tissue samples were embedded in a tissue microarray. PD-L1 will be studied by immunohistochemistry using the SP263 antibody. Stained samples will be evaluated independently by two operators. A tumor will be defined as positive when = or \>50% of tumor cells express the ligand.

The investigators will investigate the relationship between PD-L1 protein expression and overall survival and other clinical characteristics with appropriate statistical methods.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-03
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-08
• Last Update Submitted: 2017-03-08
• Study First Posted: 2017-03-14
• Last Update Posted: 2017-03-14
• Primary Completion: 2017-03-30
• Study Completion: 2017-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Early stage treatment-naive NSCLC

Exclusion Criteria

• Received any pre-surgical treatment
• no OS data available

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression	15 days	The study will investigate PD-L1 protein expression by immunohistochemistry in tumor samples from early stage NSCLC
Prognostic value	15 days	The correlation between PD-L1 protein expression by immunohistochemistry and overall survival will be studied