Efficacy of Re-challenge With Immune-Checkpoints Inhibitors in Advanced Non-Small-Cell Lung Cancer Patients: a Retrospective Observational Study (RE-CHALLENGE)

March 27, 2020 updated by: University Hospital, Grenoble

Efficacy of Re-challenge With Immune-checkpoints Inhibitors in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients: a Retrospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Immune checkpoint inhibitors (ICP), including nivolumab, pembrolizumab and atezolizumab, are currently approved by EMA (European Medicines Agency) and ANSM (National Agency for the Safety of Medicines and Health Products) for the treatment of advanced Non-Small-Cell Lung Cancer (NSCLC) in first or second line with different strategies according to the expression of PD-L1. Moreover, durvalumab recently entered the treatment strategy for locally advanced disease in PD-L1 expressing (>1%) patients. Median progression-free survival (PFS) for patients with advanced NSCLC is approximately 3 to 4 months with this kind of drugs and chemotherapy is currently the reference treatment after progression. However, the scientific community is now evaluating the re-challenge strategy. Notably, in patients with metastatic melanoma, different trials have shown the efficacy and the good safety of re-challenge with ipilimumab or a combination of nivolumab and ipilimumab after an initial period of disease control with ipilimumab.

To date, no studies have reported the clinical benefit of ICP re-challenge in patients with advanced NSCLC. The effectiveness and tolerance of the re-challenge strategy with the same or another ICP remains therefore a major issue.

Study Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • La Tronche, Isère, France, 38700
        • University Hosipital, Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective, French, multicentre cohort

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 1 year
Overall Survival
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 1 year
Progression Free Survival
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Elisa Gobinni, MD, University Hospital, Grenoble
  • Principal Investigator: Matteo Giaj Levra, pHD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2019

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC19.005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung Cancer

Clinical Trials on No interventional study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe