Effect of Chemotherapy on PD-L1 in NSCLC

Effect of Platinum-based Chemotherapy on PD-L1 Expression in Patients With Advanced Non-small Cell Lung Cancer

PD-L1 is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect PD-L1 in advanced NSCLC patients. The present study aims to evaluate whether PD-L1 will change after receiving chemotherapy in advanced NSCLC patients.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy; Immunotherapy; PD-L1
• Intervention / Treatment: Other: PD-L1 group

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Recruiting
      • Shanghai Changzheng Hospital
      • Principal Investigator: Yuansheng Zang, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Advanced NSCLC without druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)

Description

Inclusion Criteria:

• Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
• Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
• ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

• Patient can not comply with research program requirements or follow-up;
• Patient will receive immunotherapy;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PD-L1	Other: PD-L1 group; PD-L1 expression is evaluated using immunohistochemical assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with PD-L1 positive as assessed by immunohistochemical assay	PD-L1 will be calculated using immunohistochemical assay	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Baodong Qin

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ANTICIPATED): February 28, 2019
• Study Completion (ANTICIPATED): August 31, 2019

Study Registration Dates

• First Submitted: September 16, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (ACTUAL): October 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: COPDL1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No