Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator

June 30, 2020 updated by: LJ Hwu, Chung Shan Medical University

Change in Neutrophil to Lymphocyte Ratio (NLR) and Survival Among Advanced Lung Cancer Patients Receiving Immune Checkpoint Inhibitors With Immunomodulator: a Retrospective Study

The main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (NLR) after 6-week treatment of immune checkpoint inhibitors (ICIs) with or without immunomodulatory drugs and recognize the effect of post-treatment NLR and overall survival in advanced lung cancer patients by retrospective review.

Study Overview

Status

Completed

Conditions

Detailed Description

In recent years, the therapeutic strategies for lung cancer have been enriched with small molecular targeted therapy and immunotherapy. In this retrospective study, we will observe the change in NLR and explore its possible association with survival among advanced lung cancer patients receiving Immune checkpoint inhibitors (ICIs) with and without such immuno-modulator, Astragalus Polysaccharide Injection. It can be used to understand the relationship between NLR values and the survival rate of lung cancer patients after ICIs treatment. Physicians can refer to this result to give patients the suitable treatment recommendations.

Study Type

Observational

Enrollment (Actual)

53

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

  • Taiwan
      • Taichung, Taiwan
        • Chung Shan Medical University 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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with lung cancer undergoing ICIs with or without immunomodulatory drug

Description

Inclusion Criteria

  • Aged 20 years and older.
  • Patients who have been given a diagnosis of lung cancer.
  • Previously advanced lung cancer patients first treated with ICIs from Oct 1, 2015 to Oct 31, 2019.

Exclusion Criteria

  • Patients who have no hematological laboratory data available at baseline (within 3 days prior to ICI treatment) and the 6th week (± 2 weeks) after ICI treatment initiation.

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
Cohort 1：ICI treatment with immunomodulator
Lung cancer patients received immunological checkpoint inhibitors (ICIs) and any immunomodulatory drugs.
Cohort 2：ICI treatment without immunomodulator
Lung cancer patients received immunological checkpoint inhibitors (ICIs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neutrophil to lymphocyte ratio (NLR)
Time Frame: Baseline, 4~8 week
Baseline, 4~8 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 4 years
4 years

Collaborators and Investigators

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

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Shih-Ming TSAI, M.D., Ph.D., Chung Shan Medical University

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)

April 14, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMUH02-NLR

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

No

Studies a U.S. FDA-regulated device product

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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