Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04640935
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2020-11-09
Brief Title:
Paclitaxel in Combination With Bevacizumab in Patients With Stage IV NSCLC
Sponsor:
Centre Hospitalier Annecy Genevois
Organization:
Centre Hospitalier Annecy Genevois
Study Overview
Official Title:
Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2020-11
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:
AVATAX
Brief Summary:
The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice with subgroup analyses of the following patients patients who have previously received immunotherapy patients with an EGFR or ALK oncogenic addiction pathway patients who have previously received taxanes or anti-angiogenic agents
Detailed Description:
Lung and bronchopulmonary cancer is the leading cause of cancer death in France and worldwide It is diagnosed at the metastatic stage from the outset in approximately 50 of cases Non-small cell lung cancers NSCLC are the most frequent histological forms of lung cancer approximately 85 of cases with a predominance of the non-epidermal type
The increase in the number of treatments available improved supportive care and better patient selection have in recent years made it possible to expand the range of first-line chemotherapy treatments available at delà and have contributed to the increase in overall survival OS As a result nearly 80 of patients with metastatic NSCLC receive a second line of treatment The main objective in these often symptomatic patients is a satisfactory tumor control rate with acceptable tolerability
For a long time the second-line reference chemotherapy has been docetaxel or pemetrexed as monotherapy with modest results Alternative treatments such as the combination of paclitaxel chemotherapy-bevacizumab anti-angiogenic monoclonal antibody have been studied Since 2010 by analogy with breast cancer and in the absence of therapeutic alternatives the paclitaxel-bevacizumab doublet has been used in non-epidermal stage IV NSCLC in France The value of combining taxane chemotherapy with an anti-angiogenic molecule has been demonstrated in two Phase 3 clinical trials Thus this combination is an integral part of the possible treatments in 2nd line and beyond registered since 2016 in the treatment guidelines for non-epidermal NSCLC
The first-line therapeutic strategy will also be redefined in 2019 with the use of immunotherapy for a majority of patients Subsequent treatment lines will be modified with a focus on chemotherapy in particular the paclitaxel-bevacizumab combination
As this combination has been used in current practice for several years and in view of the upcoming changes to the first and second line of NSCLC treatment data on the efficacy and tolerance of this combination in real life are needed to guide our practices Recent studies are also looking at the efficacy of chemotherapy particularly taxane chemotherapy associated with an anti-angiogenic agent after a previous line including immunotherapy with a favorable signal
The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice with subgroup analyses of the following patients patients who have previously received immunotherapy patients with an EGFR or ALK oncogenic addiction pathway patients who have previously received taxanes or anti-angiogenic agents
The increase in the number of treatments available improved supportive care and better patient selection have in recent years made it possible to expand the range of first-line chemotherapy treatments available at delà and have contributed to the increase in overall survival OS As a result nearly 80 of patients with metastatic NSCLC receive a second line of treatment The main objective in these often symptomatic patients is a satisfactory tumor control rate with acceptable tolerability
For a long time the second-line reference chemotherapy has been docetaxel or pemetrexed as monotherapy with modest results Alternative treatments such as the combination of paclitaxel chemotherapy-bevacizumab anti-angiogenic monoclonal antibody have been studied Since 2010 by analogy with breast cancer and in the absence of therapeutic alternatives the paclitaxel-bevacizumab doublet has been used in non-epidermal stage IV NSCLC in France The value of combining taxane chemotherapy with an anti-angiogenic molecule has been demonstrated in two Phase 3 clinical trials Thus this combination is an integral part of the possible treatments in 2nd line and beyond registered since 2016 in the treatment guidelines for non-epidermal NSCLC
The first-line therapeutic strategy will also be redefined in 2019 with the use of immunotherapy for a majority of patients Subsequent treatment lines will be modified with a focus on chemotherapy in particular the paclitaxel-bevacizumab combination
As this combination has been used in current practice for several years and in view of the upcoming changes to the first and second line of NSCLC treatment data on the efficacy and tolerance of this combination in real life are needed to guide our practices Recent studies are also looking at the efficacy of chemotherapy particularly taxane chemotherapy associated with an anti-angiogenic agent after a previous line including immunotherapy with a favorable signal
The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice with subgroup analyses of the following patients patients who have previously received immunotherapy patients with an EGFR or ALK oncogenic addiction pathway patients who have previously received taxanes or anti-angiogenic agents
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