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CompletedNCT01763671UltimateUpdated Mar 14, 2023

Paclitaxel-bevacizumab in Advanced Lung Cancer

A Phase 3 interventional study of Docetaxel and Paclitaxel in Non-squamous Non-small Cell Lung Cancer, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Completed at 55 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Non-squamous Non-small Cell Lung Cancer

Keywords

  • Lung cancer
  • Paclitaxel bevacizumab
  • IFCT
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 166 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique is the lead sponsor of 57 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
166 participants (actual)

Study arms

  • Active comparator
    Docetaxel

    Drug: Docetaxel

  • Experimental
    Paclitaxel - Bevacizumab

    Drug: Paclitaxel · Drug: Bevacizumab

Interventions

  • DrugDocetaxel

    75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.

  • DrugPaclitaxel

    90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.

  • DrugBevacizumab

    10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.

06

What researchers measure

Primary outcomes

  1. Progression free survival

    Time between inclusion and progression

    Time frame: about 4 months

Secondary outcomes

  1. Response Rate

    Time frame: At 8 weeks

  2. Overall survival

    Time between inclusion and death

    Time frame: about 8 months

07

Study locations

55 sites
  • Amiens - CHU
    Amiens, France
  • Centre Hospitalier
    Annemasse, France
  • Hôpital Privé d'Antony
    Antony, France
  • Avignon - Institut Sainte-Catherine
    Avignon, 84918, France
  • CH de la Côte Basque
    Bayonne, France
  • Bordeaux - Polyclinique Nord
    Bordeaux, 33300, France
  • Béziers - CH
    Béziers, 34525, France
  • Caen - Centre François Baclesse
    Caen, 14000, France
  • Caen - CHU Côte de Nacre
    Caen, 14000, France
  • Castelnau Le Lez - Clinique
    Castelnau, 34170, France
  • CH de Chartres Hôpital Louis Pasteur
    Chartres, France
  • Chauny - CH
    Chauny, France
  • CH
    Cholet, France
  • Hôpital Percy-Armées - Pneumologie
    Clamart, 92140, France
  • Hôpitral Gabriel Montpied - Pneumologie
    Clermont-Ferrand, France
  • CH
    Colmar, France
  • CH Compiègne - Pneumologie
    Compiègne, France
  • CHI Créteil
    Créteil, France
  • CHRU Grenoble
    Grenoble, France
  • Harfleur - Clinique du Petit Colmoulins
    Harfleur, 76700, France
  • CH Région Saint-Omer
    Helfaut, France
  • Le Mans - Centre Hospitalier
    Le Mans, 72000, France
  • CHU (Hôpital Calmette) - Pneumologie
    Lille, 59000, France
  • CH de Longjumeau
    Longjumeau, France
  • Lorient - CHBS
    Lorient, France
  • Lyon - Hôpital Jean Mermoz
    Lyon, France
  • Lyon - Hôpital Louis Pradel (Pneumologie)
    Lyon, France
  • CH de Macon
    Macon, France
  • Mantes La Jolie - CH
    Mantes La Jolie, 78200, France
  • Marseille - Hôpital Sainte Marguerite
    Marseille, 13000, France
  • Maubeuge - Polyclinique du Parc
    Maubeuge, 59600, France
  • CH Montélimar
    Montélimar, France
  • Mulhouse - CH
    Mulhouse, 68000, France
  • Nantes - Centre René Gauducheau
    Nantes, 44805, France
  • CHR d'Orléans La Source
    Orléans, France
  • Paris - Saint Louis
    Paris, 75000, France
  • Hopital Tenon - Pneumologie
    Paris, 75020, France
  • HIA Val-de-Grâce
    Paris, France
  • Hôpital Bichat - Claude - Bernard
    Paris, France
  • Paris - Pitié-salpêtrière
    Paris, France
  • Pau - CH
    Pau, 64046, France
  • Lyon Sud
    Pierre Bénite, 69495, France
  • Rouen - CHU
    Rouen, 76000, France
  • Saint Quentin - CH
    Saint Quentin, 02100, France
  • CHU Saint-Etienne Pneumologie
    Saint-Etienne, 42000, France
  • Strasbourg - NHC
    Strasbourg, 63000, France
  • Suresnes - Hopital Foch
    Suresnes, 92151, France
  • Thonon les bains - CH
    Thonon les bains, 74200, France
  • Toulon - CHI
    Toulon, 83000, France
  • Toulon - HIA
    Toulon, 83000, France
  • Toulouse - CHU Larrey
    Toulouse, France
  • Tours - CHU
    Tours, 37000, France
  • Valenciennes - Clinique
    Valenciennes, 59304, France
  • CH de Villefranche - Pneumologie
    Villefranche, France
  • Institut Gustave Roussy
    Villejuif, 94800, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01763671
Lead sponsor
Intergroupe Francophone de Cancerologie Thoracique
Responsible party
Sponsor
First posted
Jan 9, 2013
Start date
May 2013
Primary completion
Dec 2015
Completion
Apr 2017
Last update
Mar 14, 2023

Study contacts

Alexis CORTOT, MD
principal investigator · CHRU Lille
Benjamin BESSE, MD
principal investigator · Gustave Roussy, Cancer Campus, Grand Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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