Biomarkers to Predict the Response to Pembrolizumab in Chinese NSCLC Patients

September 1, 2020 updated by: Kiang Wu Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kiang Wu Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yabing Cao, MD; PhD, Kiang Wu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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