Effect of Chemotherapy on PD-L1 in NSCLC

NCT03701607 | Unknown

• 1 other identifier: COPDL1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy; Immunotherapy; PD-L1

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PD-L1

Other: PD-L1 group

Interventions

PD-L1 group OTHER

PD-L1 expression is evaluated using immunohistochemical assay

PD-L1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baodong Qin: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: October 10, 2018
• Study Start: September 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: August 31, 2019
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)