Non-squamous Non-small Cell Lung CancerPhase 3UltimateNCT01763671
Paclitaxel-bevacizumab in Advanced Lung Cancer
A Phase 3 study testing Docetaxel, Paclitaxel and Bevacizumab in people with Non-squamous Non-small Cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 55 sites in France.
Trial summary
The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel. Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- Docetaxel, Paclitaxel and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 55 sitesFrance
- Study dates
- May 2013to Apr 2017
- Phase
- Phase 3
- 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
Who may be able to join
- 2nd or 3rd line of non squamous non small cell lung cancer of stage III or IV
- Document progression at the time of the inclusion. At least, one previous chemotherapy line with platinum. Patient who had previous treatment with bevacizumab can be included.
- Patient with active mutation of EGFR must have had on line of chemotherapy with platinum and one with Tyrosine kinase inhibitor of EGFR.
- Patient with ALK rearrangement must have had at least one line of chemotherapy with platinum and one with crizotinib.
Who cannot join
- Mixed cancer small cells and non small cells or squamous lung cancer.
- Central nervous system symptomatic metastasis or requiring immediate cerebral radiotherapy
- patient who have had previous treatment with taxane (docetaxel, paclitaxel). Peri-operatory chemotherapy or chemoradiotherapy with taxane allowed if stopped more than 6 months before.
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
France55 sites
Amiens - CHU
Amiens
Centre Hospitalier
Annemasse
Hôpital Privé d'Antony
Antony
Avignon - Institut Sainte-Catherine
Avignon, 84918
CH de la Côte Basque
Bayonne
Béziers - CH
Béziers, 34525
Bordeaux - Polyclinique Nord
Bordeaux, 33300
Caen - Centre François Baclesse
Caen, 14000
Caen - CHU Côte de Nacre
Caen, 14000
Castelnau Le Lez - Clinique
Castelnau, 34170
CH de Chartres Hôpital Louis Pasteur
Chartres
Chauny - CH
Chauny
CH
Cholet
Hôpital Percy-Armées - Pneumologie
Clamart, 92140
Hôpitral Gabriel Montpied - Pneumologie
Clermont-Ferrand
CH
Colmar
CH Compiègne - Pneumologie
Compiègne
CHI Créteil
Créteil
CHRU Grenoble
Grenoble
Harfleur - Clinique du Petit Colmoulins
Harfleur, 76700
CH Région Saint-Omer
Helfaut
Le Mans - Centre Hospitalier
Le Mans, 72000
CHU (Hôpital Calmette) - Pneumologie
Lille, 59000
CH de Longjumeau
Longjumeau
Lorient - CHBS
Lorient
Lyon - Hôpital Jean Mermoz
Lyon
Lyon - Hôpital Louis Pradel (Pneumologie)
Lyon
CH de Macon
Mâcon
Mantes La Jolie - CH
Mantes-la-Jolie, 78200
Marseille - Hôpital Sainte Marguerite
Marseille, 13000
Maubeuge - Polyclinique du Parc
Maubeuge, 59600
CH Montélimar
Montélimar
Mulhouse - CH
Mulhouse, 68000
Nantes - Centre René Gauducheau
Nantes, 44805
CHR d'Orléans La Source
Orléans
Paris - Saint Louis
Paris, 75000
Hopital Tenon - Pneumologie
Paris, 75020
HIA Val-de-Grâce
Paris
Hôpital Bichat - Claude - Bernard
Paris
Paris - Pitié-salpêtrière
Paris
Pau - CH
Pau, 64046
Lyon Sud
Pierre-Bénite, 69495
Rouen - CHU
Rouen, 76000
CHU Saint-Etienne Pneumologie
Saint-Etienne, 42000
Saint Quentin - CH
Saint-Quentin, 02100
Strasbourg - NHC
Strasbourg, 63000
Suresnes - Hopital Foch
Suresnes, 92151
Thonon les bains - CH
Thonon-les-Bains, 74200
Toulon - CHI
Toulon, 83000
Toulon - HIA
Toulon, 83000
Toulouse - CHU Larrey
Toulouse
Tours - CHU
Tours, 37000
Valenciennes - Clinique
Valenciennes, 59304
CH de Villefranche - Pneumologie
Villefranche
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer
The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.
Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.
Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- Docetaxel, Paclitaxel, Bevacizumab
- Keywords
- Lung cancer, Paclitaxel bevacizumab, IFCT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
PaclitaxelDrug
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
BevacizumabDrug
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
| Paclitaxel - Bevacizumab | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Time between inclusion and progression
Measured: about 4 months
Secondary outcomes (2)
Response Rate
Measured: At 8 weeks
Overall survival
Time between inclusion and death
Measured: about 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-squamous 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis CORTOT, MD, Principal investigator, CHRU LILLEBenjamin BESSE, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763671
- Sponsor's protocol ID
- IFCT-1103
- Acronym
- Ultimate
- Status last verified
- Mar 2023
- First submitted
- 7 Jan 2013
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cortot AB, Audigier-Valette C, Molinier O, Le Moulec S, Barlesi F, Zalcman G, Dumont P, Pouessel D, Poulet C, Fontaine-Delaruelle C, Hiret S, Dixmier A, Renault PA, Becht C, Raffy O, Dayen C, Mazieres J, Pichon E, Langlais A, Morin F, Moro-Sibilot D, Besse B. Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study. Eur J Cancer. 2020 May;131:27-36. doi: 10.1016/j.ejca.2020.02.022. Epub 2020 Apr 8.
PubMed 32276179
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer
- ClinicalTrials.gov ID
- NCT01763671
- Acronym / sponsor ID
- Ultimate / IFCT-1103
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Keywords
- Lung cancer, Paclitaxel bevacizumab, IFCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Jan 2013 (estimated)
- 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 study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.
Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.
Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: Docetaxel |
| Paclitaxel - Bevacizumab | Experimental | Drug: Paclitaxel, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 2nd or 3rd line of non squamous non small cell lung cancer of stage III or IV
- Document progression at the time of the inclusion. At least, one previous chemotherapy line with platinum. Patient who had previous treatment with bevacizumab can be included.
- Patient with active mutation of EGFR must have had on line of chemotherapy with platinum and one with Tyrosine kinase inhibitor of EGFR.
- Patient with ALK rearrangement must have had at least one line of chemotherapy with platinum and one with crizotinib.
Key exclusion criteria (3 listed)
- Mixed cancer small cells and non small cells or squamous lung cancer.
- Central nervous system symptomatic metastasis or requiring immediate cerebral radiotherapy
- patient who have had previous treatment with taxane (docetaxel, paclitaxel). Peri-operatory chemotherapy or chemoradiotherapy with taxane allowed if stopped more than 6 months before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Docetaxel |
| Paclitaxel90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Paclitaxel - Bevacizumab |
| Bevacizumab10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Paclitaxel - Bevacizumab |
Primary outcome
Progression free survival
Time frame: about 4 months
Time between inclusion and progression
2 secondary outcomes
Response Rate
Time frame: At 8 weeks
Overall survival
Time frame: about 8 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 14 Mar 2023.
- Derived from this study: PubMed 32276179Cortot AB, Audigier-Valette C, Molinier O, Le Moulec S, Barlesi F, Zalcman G, Dumont P, Pouessel D, Poulet C, Fontaine-Delaruelle C, Hiret S, Dixmier A, Renault PA, Becht C, Raffy O, Dayen C, Mazieres J, Pichon E, Langlais A, Morin F, Moro-Sibilot D, Besse B. Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study. Eur J Cancer. 2020 May;131:27-36. doi: 10.1016/j.ejca.2020.02.022. Epub 2020 Apr 8.
- Official IFCT websiteLink provided by the sponsor.
Related trials for Non-squamous Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Alexis CORTOT, MD principal investigator
CHRU LILLE
Benjamin BESSE, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel, Paclitaxel and Bevacizumab in people with Non-squamous Non-small Cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 55 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 4 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: about 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01763671, which also lists 1 linked publication.
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 14 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.