Prognostic Value of PD-L1 in NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

The Prognostic Value of the Expression of Programmed Death Ligand 1 (PD-L1) in Early Stage Non-small-cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03078959
• Other study ID #: L3P1490
• Status: Active, not recruiting
• Phase: N/A
• First received: March 3, 2017
• Last updated: March 8, 2017
• Start date: March 3, 2017
• Est. completion date: April 15, 2017

Study information

• Verified date: March 2017
• Source: Fondazione Ricerca Traslazionale
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: April 15, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Early stage treatment-naive NSCLC

Exclusion Criteria:

• Received any pre-surgical treatment

• no OS data available

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Other:
• immunohistochemistry
Samples will be stained using the SP263 antibody clone against PD-L1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Ricerca Traslazionale

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression	The study will investigate PD-L1 protein expression by immunohistochemistry in tumor samples from early stage NSCLC	15 days
Primary	Prognostic value	The correlation between PD-L1 protein expression by immunohistochemistry and overall survival will be studied	15 days