Biomarkers to Predict the Response to Pembrolizumab in Chinese NSCLC Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NSCLC Stage IV Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kiang Wu Hospital

Macao, 999078, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Above 18 years of age
Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
With PD-L1test available
Progressed on previous treatment, or treatment native patients. Patients may have also received additional lines of treatment
Received pembrolizumab treatment in the participating site.

Exclusion criteria

Enrollment in studies that prohibit any participation in this observational study
No serum samples available

Treatment and study plan

Pembrolizumab

Drug

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.

Primary outcomes

Overall response rate

Time frame: Disease response is assessed every 3 weeks for the first 18 weeks and then every 12 weeks until disease progression (worsens) or study completion, an average of 24 months.

To assess the real world effectiveness of pembrolizumab treatment in locally advanced or metastatic NSCLC patients with PD-L1 positive in terms of response rate

Sponsors and collaborators

Lead sponsor

Kiang Wu Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Sep 3, 2019
Registry last updated: Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed