- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352335
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
-
-
-
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
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
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.
Clinical Trials on Advanced Lung Cancer
-
Mythic TherapeuticsRecruitingNon-Small Cell Lung Cancer | NSCLC | Advanced Non-Small Cell Lung Cancer | NSCLC Stage IV | NSCLC Stage IIIB | Advanced Non-Small Cell Squamous Lung Cancer | Advanced Non-Small Cell Non-Squamous Lung CancerUnited States, Taiwan, Korea, Republic of, Australia, United Kingdom, Spain
-
NeogenTCNot yet recruitingAdvanced Breast Cancer | Advanced Lung Cancer
-
Shanghai Fosun Pharmaceutical Industrial Development...RecruitingAdvanced Solid Tumor | Advanced Cancer | Lung Cancer, Nonsmall CellChina
-
Mersana TherapeuticsCompletedAdvanced Breast Cancer | Advanced Gastric Cancer | Advanced Nonsmall Cell Lung CancerUnited States
-
Ruijin HospitalActive, not recruitingAdvanced Cancer | Locally Advanced Cancer | Pulmonary NeoplasmChina
-
AstraZenecaCompletedAdvanced Non Small Cell Lung Cancer | Advanced (Inoperable) Non Small Cell Lung CancerFrance, Korea, Republic of, United Kingdom, Spain
-
Arcus Biosciences, Inc.RecruitingAdvanced CancerUnited States
-
AstraZenecaCompletedAdvanced Non Small Cell Lung Cancer | Advanced (Inoperable) Non Small Cell Lung CancerBelgium, United States, Korea, Republic of, Taiwan, United Kingdom, Netherlands
-
AstraZenecaCompletedAdvanced Non Small Cell Lung Cancer | Advanced (Inoperable) Non Small Cell Lung CancerUnited States, France, Germany, Korea, Republic of, Taiwan, United Kingdom, Spain, Italy, Japan, Australia
-
Mirati Therapeutics Inc.TerminatedAdvanced CancerUnited States