Effect of Chemotherapy on PD-L1 in NSCLC

• Conditions: Chemotherapy; Immunotherapy; PD-L1
• Interventions: Other: PD-L1 group

• Registration Number: NCT03701607
• Lead Sponsor: Baodong Qin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-16
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-08
• Last Update Submitted: 2018-10-08
• Study First Posted: 2018-10-10
• Last Update Posted: 2018-10-10
• Primary Completion: 2019-02-28
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PD-L1	PD-L1 group	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China