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Completed

NCT Number: NCT04352335

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

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.

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Key information

Conditions

Advanced Lung Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chung Shan Medical University Hospital

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Neutrophil to lymphocyte ratio (NLR)

    Time frame: Baseline, 4~8 week

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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