NCT04352335

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

April 16, 2020

Last Update Submit

June 30, 2020

Conditions

Advanced Lung Cancer

Keywords

neutrophil to lymphocyte ratio (NLR)immunomodulator

Outcome Measures

Primary Outcomes (1)

  • Neutrophil to lymphocyte ratio (NLR)

    Baseline, 4~8 week

Secondary Outcomes (1)

  • Overall Survival (OS)

    4 years

Study Arms (2)

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).

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lung cancer undergoing ICIs with or without immunomodulatory drug

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Study Officials

  • Shih-Ming TSAI, M.D., Ph.D.

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 20, 2020

Study Start

April 14, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)