NCT03486119

Brief Summary

The study aimed to elucidate predictive immune related biomarker to the responsiveness to the PD-1 blockade and evaluate the dynamics of immune cells in peripheral blood from NSCLC patients during nivolumab treatment. Hypothesis that The ratio of MDSC after 1st or 2nd cycle can predict the response to nivolumab in NSCLC patients earlier than the tumor assessment by imaging scan. The primary objective is to determine whether myeloid-derived suppressor cell (MDSC) ratio after 1st or 2nd cycle of nivolumab can be accurate predictive biomarkers of nivolumab in advanced NSCLC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2.4 years

First QC Date

March 7, 2018

Last Update Submit

October 14, 2020

Conditions

Non -Small Cell Lung Cancer

Keywords

Non -small cell lung cancer

Outcome Measures

Primary Outcomes (6)

  • MDSC markers

    CD11b, Gr11b,

    change from baseline blood biomarker at 6 weeks or progression

  • Changes of Tregs markers

    FOXP3, CD25, CD127, CD45RA

    A) Within 7 days before treatment (Pre-treatment) B) Every 2 weeks of treatment up to 3 cycles (every cycle is 2 weeks)C) Within 28 days after progression (post-treatment)

  • T cell/NK cell marker

    CD3, CD4, CD8, FoxP3, CD56

    A) Within 7 days before treatment (Pre-treatment) B) Every 2 weeks of treatment up to 3 cycles (every cycle is 2 weeks)C) Within 28 days after progression (post-treatment)

  • Immune checkpoint molecules

    PD-1, LAG-3, TIGIT etc.

    A) Within 7 days before treatment (Pre-treatment) B) Every 2 weeks of treatment up to 3 cycles (every cycle is 2 weeks)C) Within 28 days after progression (post-treatment)

  • serum levels of S100A8/A9

    A) Within 7 days before treatment (Pre-treatment) B) Every 2 weeks of treatment up to 3 cycles (every cycle is 2 weeks)C) Within 28 days after progression (post-treatment)

  • HMGB1

    A) Within 7 days before treatment (Pre-treatment) B) Every 2 weeks of treatment up to 3 cycles (every cycle is 2 weeks)C) Within 28 days after progression (post-treatment)

Secondary Outcomes (4)

  • ORR(Objective response rate)

    every 6 months up to 5years.

  • PFS (progression free survival)

    every 6 months up to 5years.

  • OS (overall survival)

    every 6 months up to 5years.

  • Adverse Event

    up to 12 months

Interventions

nivolumabOTHER

Subjects will be treated with 3mg/kg in nivolumab IV every 2 weeks for a maximum of 12 months.

Eligibility Criteria

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

The sample size is not based on statistical consideration. This is pilot study designed to explore biomarker to early predict the response to nivolumab in NSCLC. We decided to 60 subjects considering feasibility.

You may qualify if:

  • Age≥ 18 years old.
  • Histologically confirmed advanced NSCLC
  • Metastatic or recurrent stage
  • Failed to previous platinum based chemotherapy
  • Performance status of Eastern Cooperative Oncology Group 0 to 1.
  • Adequate organ function
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

You may not qualify if:

  • Symptomatic or uncontrolled brain metastasis
  • History of autoimmune disease
  • Other primary cancer within 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Yonsei University College of Medicine

Seoul, Korea, 03722, South Korea

Location

Related Publications (1)

  • Kim CG, Hong MH, Kim KH, Seo IH, Ahn BC, Pyo KH, Synn CB, Yoon HI, Shim HS, Lee YI, Choi SJ, Lee YJ, Kim EJ, Kim Y, Kwak JE, Jung J, Park SH, Paik S, Shin EC, Kim HR. Dynamic changes in circulating PD-1+CD8+ T lymphocytes for predicting treatment response to PD-1 blockade in patients with non-small-cell lung cancer. Eur J Cancer. 2021 Jan;143:113-126. doi: 10.1016/j.ejca.2020.10.028. Epub 2020 Dec 7.

    PMID: 33302114DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

April 3, 2018

Study Start

February 5, 2018

Primary Completion

July 7, 2020

Study Completion

July 7, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)