Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03801304
Status:
COMPLETED
Last Update Posted:
2022-05-12
First Post:
2019-01-07
Brief Title:
Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Open Label Phase II Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VinMetAtezo
Brief Summary:
The majority of patients diagnosed with advanced NSCLC are treated with platinum-doublet chemotherapy regimens except those harboring specific oncogenic drivers such as epidermal growth-factor-receptor EGFR mutations or anaplastic lymphoma kinase ALK rearrangements In the second-line setting response rates remain low and median survival rarely exceeds 10 months
Over the past few years several checkpoint inhibitors targeting programmed cell death protein-1 PD1 or its ligand PDL1 used as second-line therapies generated evidence of improving survival and more recently as first-line NSCLC treatment
Although pembrolizumab anti-PD1 was recently approved as first-line treatment for patients with at least 50 of their NSCLC cells expressing PDL1 many patients are still not benefiting from this first-line agent
For patients with relapsed NSCLC atezolizumab anti-PDL1 prolonged survival compared to docetaxel in the phase II POPLAR and phase III OAK trials Novel concepts of synergic action between immunotherapy and chemotherapy have emerged recently However those types of treatments are given for different durations chemotherapy is allowed for only a short period rarely exceeding 6 cycles while anti-PDL1 can be continued for several months until loss of its clinical benefit
Metronomic chemotherapy is defined as low-dose and frequent chemotherapy administration without prolonged drug-free breaks Metronomic administration of oral vinorelbine has been tested against breast cancer and advanced refractory NSCLC The combination could have immunostimulatory effects induction of immunogenic cancer-cell death enhancement of antigen presentation through dendritic cell modulation increased cancer-cell immunogenicity preferential depletion of regulatory T cells modulation of myeloid-derived suppressor cells enhancement of the cytotoxic activity of immune-effector cells
Over the past few years several checkpoint inhibitors targeting programmed cell death protein-1 PD1 or its ligand PDL1 used as second-line therapies generated evidence of improving survival and more recently as first-line NSCLC treatment
Although pembrolizumab anti-PD1 was recently approved as first-line treatment for patients with at least 50 of their NSCLC cells expressing PDL1 many patients are still not benefiting from this first-line agent
For patients with relapsed NSCLC atezolizumab anti-PDL1 prolonged survival compared to docetaxel in the phase II POPLAR and phase III OAK trials Novel concepts of synergic action between immunotherapy and chemotherapy have emerged recently However those types of treatments are given for different durations chemotherapy is allowed for only a short period rarely exceeding 6 cycles while anti-PDL1 can be continued for several months until loss of its clinical benefit
Metronomic chemotherapy is defined as low-dose and frequent chemotherapy administration without prolonged drug-free breaks Metronomic administration of oral vinorelbine has been tested against breast cancer and advanced refractory NSCLC The combination could have immunostimulatory effects induction of immunogenic cancer-cell death enhancement of antigen presentation through dendritic cell modulation increased cancer-cell immunogenicity preferential depletion of regulatory T cells modulation of myeloid-derived suppressor cells enhancement of the cytotoxic activity of immune-effector cells
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None