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

Advanced Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352335
• Other study ID #: CSMUH02-NLR
• Status: Completed
• Start date: April 14, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: June 2020
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutrophil to lymphocyte ratio (NLR)		Baseline, 4~8 week
Secondary	Overall Survival (OS)		4 years