Effect of Chemotherapy on PD-L1 in NSCLC

Immunotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701607
• Other study ID #: COPDL1
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2018
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chemotherapy
• Immunotherapy
• PD-L1

Intervention

Other:
• PD-L1 group
PD-L1 expression is evaluated using immunohistochemical assay

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Baodong Qin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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