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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03701607
Other study ID # COPDL1
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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