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Trial record 2 of 3 for:    checkmate 227

Effect of Chemotherapy on PD-L1 in NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03701607
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Information provided by (Responsible Party):
Baodong Qin, Shanghai Changzheng Hospital

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.

Condition or disease Intervention/treatment
Chemotherapy Immunotherapy PD-L1 Other: PD-L1 group

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Platinum-based Chemotherapy on PD-L1 Expression in Patients With Advanced Non-small Cell Lung Cancer
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Number of participants with PD-L1 positive as assessed by immunohistochemical assay [ Time Frame: through study completion, an average of 1 year ]
    PD-L1 will be calculated using immunohistochemical assay

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Advanced NSCLC without druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03701607

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China, Shanghai
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200003
Contact: Xiao-Dong Jiao, MD    +86-13817797639   
Principal Investigator: Yuansheng Zang, Professor         
Sponsors and Collaborators
Baodong Qin
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Responsible Party: Baodong Qin, Principal Investigator, Shanghai Changzheng Hospital Identifier: NCT03701607    
Other Study ID Numbers: COPDL1
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No