Non Small Cell Lung CancerAVATAXNCT04640935
Paclitaxel in Combination With Bevacizumab in Patients With Stage IV NSCLC.
An observational study of Non Small Cell Lung Cancer, run by Centre Hospitalier Annecy Genevois at 15 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 320 participants
- Where
- 15 sitesFrance
- Study dates
- 1 Oct 2019to 5 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include all eligible patients who started paclitaxel-bevacizumab between January 1, 2010 and May 1, 2018. The number of patients is estimated to be approximately 200.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Hôpital Ambroise Paré AP-HP
Boulogne-Billancourt
Centre Hospitalier Universitaire Brest
Brest
Centre Hospitalier Métropole Savoie
Chambéry
Centre Hospitalier Intercommunal de Créteil
Créteil
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble
Centre Hospitalier de Versailles André Mignot
Le Chesnay
Centre Hospitalier Universitaire de Lille
Lille
Centre Léon Bérard Lyon
Lyon
Hospices Civils de Lyon
Lyon
Centre Hospitalier François Quesnay
Mantes-la-Jolie
Centre Hospitalier Annecy Genevois
Metz-Tessy, 74374
Institut Curie
Paris
Institut Curie Saint Cloud
Saint-Cloud
Institut de Cancérologie Lucien Neuwirth
Saint-Etienne
Hôpital Foch
Suresnes
About this study
Official title: Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).
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.
Read the 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 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.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancers, Paclitaxel, Bevacizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (8)
Drugs administration dosage description
Description of the different monthly drug administration regimens
Measured: Up to 12 months
Objective response rate and control rate
Objective response rate and control rate according to RECIST 1.1 criteria in the general population
Measured: Up to 12 months
Overall survival Rate
Overall survival, assessed on the whole population
Measured: Up to 12 months
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;
Measured: Up to 12 months
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;
Measured: Up to 12 months
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;
Measured: Up to 12 months
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;
Measured: Up to 12 months
Frequency of safety events
Frequency of grade ≥3 adverse events and frequency of discontinuation of paclitaxel-bevacizumab for toxicity ;
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Oct 2019
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Chantal Decroisette, Principal investigator, CH Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640935
- Sponsor's protocol ID
- 19-09
- Acronym
- AVATAX
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).
- ClinicalTrials.gov ID
- NCT04640935
- Acronym / sponsor ID
- AVATAX / 19-09
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancers, Paclitaxel, Bevacizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all eligible patients who started paclitaxel-bevacizumab between January 1, 2010 and May 1, 2018. The number of patients is estimated to be approximately 200.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
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.
8 secondary outcomes
Drugs administration dosage description
Time frame: Up to 12 months
Objective response rate and control rate
Time frame: Up to 12 months
Overall survival Rate
Time frame: Up to 12 months
Objective Response Rate
Time frame: Up to 12 months
Progression-Free Survival Rate
Time frame: Up to 12 months
Disease Control Rate
Time frame: Up to 12 months
Overall Survival Rate
Time frame: Up to 12 months
Frequency of safety events
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Decroisette principal investigator
CH Annecy Genevois
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Centre Hospitalier Annecy Genevois at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.