NCT03816657

Brief Summary

This retrospective study explores the combination of Programmed cell death ligand 1 (PD-L1) expression and Neutrophil to Lymphocyte Ratio (NLR) as an easy feasible panel to predict benefit to nivolumab.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Status
unknown

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 15, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

January 22, 2019

Last Update Submit

January 22, 2019

Conditions

To Define an Easy and Feasible Panel Which May be Routinely Applied to Select Patients for Immunotherapy Avoiding More Complex and Expensive Methods

Outcome Measures

Primary Outcomes (1)

  • ORR

    Overall Response Rate

    3 months

Secondary Outcomes (2)

  • PFS

    3 months

  • OS

    3 months

Study Arms (2)

Cohort1

Cohort1 (PD-L1+/low NLR)

Cohort2

Cohort 2 (PD-L1-/High NLR)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced NSCLC who received at least one cycle of nivolumab (3mg/kg intravenously every 2 weeks) within the expanded access program (EAP) or in a routine clinical practice after the drug approval

You may qualify if:

  • Patients with histologic diagnosis of advanced NSCLC who received Nivolumab as second or further line of therapy
  • Paraffin-embedded tissue sample available for PD-L1 analysis
  • disponibilità di emocromo entro 4 settimane dall'inizio del trattamento con Nivolumab
  • To calculate NLR, the absolute neutrophil count was divided by the lymphocytes value measured in peripheral blood within 4 weeks prior to the first infusion of nivolumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 25, 2019

Study Start

February 15, 2015

Primary Completion

May 15, 2017

Study Completion

March 30, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01