NCT05321212

Brief Summary

This study was a French multicentric cross-sectional study retrospectively of 108 consecutive advanced NSCLC patients with a PD-L1 TPS ≥50% and without EGFR/ALK aberrations treated by pembrolizumab in first line.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

January 2, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

Same day

First QC Date

August 7, 2019

Last Update Submit

April 1, 2022

Conditions

Carcinoma, Non-Small-Cell LungImmunotherapy

Keywords

pembrolizumabfirst line treatmentPDL1 TPS > 50%brain efficacy

Outcome Measures

Primary Outcomes (1)

  • progression free survival with pembrolizumab

    time from initiation of pembrolizumab to the date of disease progression or death

    time from initiation of pembrolizumab to the date of disease progression or death ( 20 months)

Eligibility Criteria

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

Non-small-cell lung cancer with PDL1 TPS \> 50% treated in first line with pembrolizumab

You may qualify if:

  • histologically or cytologically confirmed NSCLC PD- L1 TPS ≥ 50% stage III and IV WHO performance status of 0, 1 or 2 adequate organ function

You may not qualify if:

  • previous EGFR or ALK aberrations positive test for hepatitis B or C virus indicating acute or chronic infection known history of testing positive for human immunodeficiency virus (HIV) severe, uncontrolled autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Brest

Brest, 29609, France

Location

CHIC de QUIMPER

Quimper, 29000, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

August 7, 2019

First Posted

April 11, 2022

Study Start

January 2, 2019

Primary Completion

January 2, 2019

Study Completion

March 2, 2019

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning one year and ending five years following the publication
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR(2)