RE-CHALLENGE: Efficacy of Re-challenge With Immune-Checkpoints Inhibitors in Advanced Non-Small-Cell Lung Cancer Patients: a Retrospective Observational Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Overall Survival [1 year]
Overall Survival
Secondary Outcome Measures
- Progression Free Survival [1 year]
Progression Free Survival
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of NSCLC
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Advanced disease (stage III-IV) according to the TNM 7th /8th edition classification at the beginning of first ICP
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Patients must have received at least two lines of ICP during their history of disease
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hosipital, Grenoble | La Tronche | Isère | France | 38700 |
Sponsors and Collaborators
- University Hospital, Grenoble
- Bristol-Myers Squibb
Investigators
- Study Director: Elisa Gobinni, MD, University Hospital, Grenoble
- Principal Investigator: Matteo Giaj Levra, pHD, University Hospital, Grenoble
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 38RC19.005