NCT04076228

Biomarkers to Predict the Response to Pembrolizumab in Chinese NSCLC Patients

Immunophenotyping, Molecular Analysis and Functional Characterization of Cluster of Differentiation Expressing Cells and/or Other Immune Populations in Response to Pembrolizumab in Chinese NSCLC Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Kiang Wu Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Pembrolizumab is approved for advanced stage non-small cell lung cancer. However, the response rate is low (around 10-15 %) in patients treated in Macau SAR, China. The investigators hypothesize CD38 expressing cells and/or other immune populations will help to predict response.

Detailed description

Lung cancer is the leading cause of cancer death, the overall survival rate is low. Recently, using anti-PD-L1 immunotherapy for treatment of cancer shows promising in some types of cancer, including melanoma, head and neck squamous cell cancer, and lung cancer etc. Pembrolizumab is a FDA-approved anti-PD-L1 drug for treatment of advanced stage non-small cell lung cancer. In China, it is approved for used in Macau and Hong Kong. Biomarkers associated with predictive response includes PD-L1 high expression, high mutational burden, and T-cell infiltration based on several clinical trial studies in the western countries. However, the response rate is low (around 10-15 %) in patients treated in Macau SAR, China. The investigators hypothesize that immunophenotying, molecular analysis and functional characterization of CD38 expressing cells and/or other immune populations CD38 will help to identify predictive, Progression and resistance markers associated with PDL1 treatment response. The investigators will collect the blood samples of Pembrolizumab response and non-response Chinese lung cancer patients and compare the imumnophenotypic and molecular dynamic changes during treatment courses. The investigators will also examine the role of CD38 and other molecular markers associated with Pembrolizumab response, functional characterize in vitro. The molecular mechanism controlling Pembrolizumab response will be better understood for designing a better treatment strategy.

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	Pembrolizumab	pembrolizumab is a PD-1 inhibitor. Treatment and follow up will be performed at Kiang Wu Hospital in their clinical oncology center. Clinically pathological related information will be recorded.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-09-03
• Last updated: 2020-09-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study