Clinical trial NCT04069663: Efficacy of Re-challenge With Immune-Checkpoints Inhibitors in Advanced Non-Small-Cell Lung Cancer Patients: a Retrospective Observational Study
Official title: Efficacy of Re-challenge With Immune-checkpoints Inhibitors in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2019-08-28
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective, French, multicentre cohort

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 1 year
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: La Tronche
country: France
facility: University Hosipital, Grenoble
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Elisa Gobinni, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Grenoble
name: Matteo Giaj Levra, pHD
role: PRINCIPAL_INVESTIGATOR
References: