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

Non Small Cell Lung Cancer Clinical Trial

— RE-CHALLENGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069663
• Other study ID #: 38RC19.005
• Status: Completed
• Start date: January 22, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 15, 2019
• Est. primary completion date: May 15, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Other:
• No interventional study
Retrospective data analysis

Locations

Country	Name	City	State
France	University Hosipital, Grenoble	La Tronche	Isère

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall Survival	1 year
Secondary	Progression Free Survival	Progression Free Survival	1 year