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

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.

Study Overview

• Status: Completed
• Conditions: NSCLC Stage IV
• Intervention / Treatment: Drug: Pembrolizumab

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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• China
  • Macao, China, 999078
    • Kiang Wu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study cohort will include locally advanced or metastatic NSCLC patients with PD-L1 status available and receive pembrolizumab treatment per the judgement of treating physicians in the participating site in Macau. 30-40 patients are anticipated to be enrolled in the study, the majority of which are estimated to be from mainland China.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pembrolizumab; Chinese lung cancer patients who will receive pembrolizumab will be enrolled in this study. Clinically, the treatment course of pembrolizumab is depended on the efficacy, but average cycle is about 3-4 weeks and patient will receive 6 treatment courses.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	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	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.

Collaborators and Investigators

• Sponsor: Kiang Wu Hospital
• Investigators: Principal Investigator: Yabing Cao, MD; PhD, Kiang Wu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: NSCLC; Biomarkers; PD-L1
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pembrolizumab
• Other Study ID Numbers: KWH201702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No