This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Treatments docetaxel, paclitaxel, bevacizumab
Phase phase 3
Target VEGF
Sponsor Intergroupe Francophone de Cancerologie Thoracique
Start date May 2013
End date December 2015
Trial size 164 participants
Trial identifier NCT01763671, IFCT-1103


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
(Active Comparator)
75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.

Primary Outcomes

Progression free survival
time frame: about 4 months

Secondary Outcomes

Response Rate
time frame: At 8 weeks
Overall survival
time frame: about 8 months

Eligibility Criteria

Male or female participants at least 18 years old.

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: - 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.

Additional Information

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
Principal investigator Alexis CORTOT, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Intergroupe Francophone de Cancerologie Thoracique.