NCT04069663

Brief Summary

This is a multicentre, retrospective, national observational study aiming to describe clinical outcomes of advanced NSCLC patients that performed an ICP re-challenge during their history of disease. The objective of this study is to evaluate the ICP re-challenge efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

August 23, 2019

Last Update Submit

March 27, 2020

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall Survival

    1 year

Secondary Outcomes (1)

  • Progression Free Survival

    1 year

Interventions

No interventional studyOTHER

Retrospective data analysis

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective, French, multicentre cohort

You may qualify if:

  • Diagnosis of NSCLC
  • Advanced disease (stage III-IV) according to the TNM 7th /8th edition classification at the beginning of first ICP
  • Patients must have received at least two lines of ICP during their history of disease
  • Patients with EGFR mutation and/or ALK translocation must have received all specific target agents regularly reimbursed (during the reporting period) prior to the first PCI

You may not qualify if:

  • Opposition form signed by the living patient or opposition clearly indicated in the deceased patient's medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hosipital, Grenoble

La Tronche, Isère, 38700, 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 Officials

  • Elisa Gobinni, MD

    University Hospital, Grenoble

    STUDY DIRECTOR

  • Matteo Giaj Levra, pHD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

January 22, 2019

Primary Completion

May 15, 2019

Study Completion

October 15, 2019

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)