NCT05711914

Brief Summary

Immunotherapy has transformed cancer treatment with the PD-1 class of checkpoint inhibitors - pembrolizumab and nivolumab -- demonstrating durable responses in Stage IV metastatic tumors such as non-small cell lung cancer and melanoma. Despite these numerous successes, PD-1/PD-L1 checkpoint blockade therapies do have a number of shortcomings. Many approaches to predict response to PD-1/PD-L1 checkpoint therapy have been investigated with limited success. Recent efforts exploring the utility of quantitative imaging biomarkers to predict response to PD-\[L\]1 immunotherapy have shown promise. The purpose of this retrospective multicenter study is to develop a multi-omic classifier to predict response to PD-1/PD-L1 checkpoint blockade for mutation negative (EGFR, ALK and ROS1) NSCLC

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

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

January 31, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

January 25, 2023

Last Update Submit

January 25, 2023

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • developing a multi-omic classifier for predicting PD-1 response

    Once sufficient patient data are accumulated, imaging data (both baseline and follow-up scans) will be annotated (segmented) to delineate lesions, lymph nodes, surrounding organs, etc…

    during one month

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with non-small cell lung cancer (NSCLC), having undergone treatment with immunotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean-Paul BEREGI

Nîmes, 30900, 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
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 3, 2023

Study Start

January 31, 2021

Primary Completion

March 31, 2022

Study Completion

December 31, 2022

Last Updated

February 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)