Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients
NCT05375994
Advanced Cancer, Bronchial Neoplasms
San Francisco, California, United States
View Trial DetailsNCT Number: NCT04640935
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.
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Notify Me18 year and older
All sexes
Observational
Hôpital Ambroise Paré AP-HP, Boulogne-Billancourt, France
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 delà̀ 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 12 months
Progression-free survival with paclitaxel-bevacizumab, i.e., the time from the start of paclitaxel-bevacizumab treatment to cancer progression, estimated at 12 months in the general population.
Time frame: Up to 12 months
Description of the different monthly drug administration regimens
Time frame: Up to 12 months
Objective response rate and control rate according to RECIST 1.1 criteria in the general population
Time frame: Up to 12 months
Overall survival, assessed on the whole population
Time frame: Up to 12 months
Objective Response Rate in the following subgroups:
Time frame: Up to 12 months
Progression-Free Survival in the following subgroups:
Time frame: Up to 12 months
Disease Control in the following subgroups:
Time frame: Up to 12 months
Overall Survival in the following subgroups:
Time frame: Up to 12 months
Frequency of grade ≥3 adverse events and frequency of discontinuation of paclitaxel-bevacizumab for toxicity ;
Centre Hospitalier Annecy Genevois
Other
Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).
Acronym: AVATAX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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