Paclitaxel in Combination With Bevacizumab in Patients With Stage IV NSCLC.

Non Small Cell Lung Cancer Clinical Trial

— AVATAX  

Official title:

Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640935
• Other study ID #: 19-09
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: June 5, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Annecy Genevois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: June 5, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years old;

• Histologically or cytologically confirmed diagnosis of non-epidermal NSCLC;

• Advanced stage IV disease at the start of treatment with paclitaxel-bevacizumab according to TNM 7/8th edition classification;

• Treatment with paclitaxel-bevacizumab received as second-line therapy or beyond, in a clinical trial or not;

• Alive patients not opposed to the use of their data

Exclusion Criteria:

• Patient under guardianship or curatorship at the date of the study ;

• Patients alive at the time of the study who are opposed to the use of their data

• Opposition to the use of their data expressed during the lifetime of patients who died at the time of the study.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
France	Hôpital Ambroise Paré AP-HP	Boulogne Billancourt
France	Centre Hospitalier Universitaire Brest	Brest
France	Centre Hospitalier Métropole Savoie	Chambéry
France	Centre Hospitalier Intercommunal de Créteil	Créteil
France	Centre Hospitalier Universitaire Grenoble Alpes	Grenoble
France	Centre Hospitalier de Versailles André Mignot	Le Chesnay
France	Centre Hospitalier Universitaire de Lille	Lille
France	Centre Léon Bérard Lyon	Lyon
France	Hospices Civils de Lyon	Lyon
France	Centre Hospitalier François Quesnay	Mantes-la-Jolie
France	Centre Hospitalier Annecy Genevois	Metz-Tessy
France	Institut Curie	Paris
France	Institut Curie Saint Cloud	Saint-Cloud
France	Institut de Cancérologie Lucien Neuwirth	Saint-Étienne
France	Hôpital Foch	Suresnes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois	University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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.	Up to 12 months
Secondary	Drugs administration dosage description	Description of the different monthly drug administration regimens	Up to 12 months
Secondary	Objective response rate and control rate	Objective response rate and control rate according to RECIST 1.1 criteria in the general population	Up to 12 months
Secondary	Overall survival Rate	Overall survival, assessed on the whole population	Up to 12 months
Secondary	Objective Response Rate	Objective Response Rate in the following subgroups: patients treated after immunotherapy and especially immediately after immunotherapy; Patients with an oncogenic EGFR or ALK addiction pathway; Patients previously treated with taxanes; Patients previously treated with anti-angiogenic drugs;	Up to 12 months
Secondary	Progression-Free Survival Rate	Progression-Free Survival in the following subgroups: patients treated after immunotherapy and especially immediately after immunotherapy; Patients with an oncogenic EGFR or ALK addiction pathway; Patients previously treated with taxanes; Patients previously treated with anti-angiogenic drugs;	Up to 12 months
Secondary	Disease Control Rate	Disease Control in the following subgroups: patients treated after immunotherapy and especially immediately after immunotherapy; Patients with an oncogenic EGFR or ALK addiction pathway; Patients previously treated with taxanes; Patients previously treated with anti-angiogenic drugs;	Up to 12 months
Secondary	Overall Survival Rate	Overall Survival in the following subgroups: Patients treated after immunotherapy and especially immediately after immunotherapy; Patients with an oncogenic EGFR or ALK addiction pathway; Patients previously treated with taxanes; Patients previously treated with anti-angiogenic drugs;	Up to 12 months
Secondary	Frequency of safety events	Frequency of grade =3 adverse events and frequency of discontinuation of paclitaxel-bevacizumab for toxicity ;	Up to 12 months