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 (VinMetAtezo)
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|ClinicalTrials.gov Identifier: NCT03801304|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2019
Last Update Posted : August 7, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Atezolizumab Drug: Vinorelbine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 24, 2019|
|Estimated Primary Completion Date :||July 24, 2022|
|Estimated Study Completion Date :||July 24, 2023|
Experimental: Atezolizumab associated with vinorelbine
Atezolizumab in IV infusions
- Occurrence of death or progression of the disease [ Time Frame: 4 months ]To evaluate the occurrence of death or progression of the disease
- Emergence of adverse events (Safety and tolerability) [ Time Frame: 12 months ]To evaluate the safety outcomes, tolerability, adverse events frequency
- Occurrence of death [ Time Frame: 12 months ]To evaluate the occurrence of death over 12 months of follow-up
- Objective Response Rate [ Time Frame: 4 months ]To evaluate the objective Response Rate and Disease Control Rate
- Following of the quality of life [ Time Frame: 12 months ]The scale EuroQol 5 dimensions (EDQ5) is used to evaluate the quality of life. The EQ-5D scale is a standardised measure of health status to provide a simple, generic measure of health for clinical and economic appraisal, whih is divided by the EQ-5D descriptive system (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the EQ Visual Analogue scale (EQ VAS). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
- Following of the quality of life [ Time Frame: 12 months ]The EORTC QLQ-C30 is a questionnaire with 30 questions developed to assess the quality of life of cancer patients. An essential aspect of the "modular" approach to QOL assessment adopted by the EORTC Quality of Life Group is the development of modules specific to tumour site, treatment modality, or a QOL dimension, to be administered in addition to the core questionnaire (EORTC QLQ-C30).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801304
|CH Aix en Provence|
|CHRU de Brest - Hôpital Morvan|
|Brest, France, 29609|
|CH de Créteil|
|Créteil, France, 94010|
|Ch La Roche Sur Yon|
|La Roche Sur Yon, France, 85000|
|CHU de Limoges - Hôpital DUPUYTREN|
|Limoges, France, 87042|
|CHU de Rennes|
|Rennes, France, 35033|
|Hia Saint Anne|
|Toulon, France, 83041|