Study comparing the efficacy of paclitaxel-bevacizumab with docetaxel in 2nd or 3rd treatment of lung cancer

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 - Ultimate

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004524-38-FR

Enrollment

Unknown

Registered

2013-05-21

Start date

2013-01-31

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non squamous non small cell lung cancer of advanced stage MedDRA version: 14.1 Level: LLT Classification code 10025062 Term: Lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 151 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17

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 with taxane allowed if stopped more than 6 months before.

Design outcomes

Primary

Measure	Time frame
Main Objective: Progression free survival;Secondary Objective: Response rate Overall survival Safety Response rate and progression free survival after cross-over;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: 4 months	—

Secondary

Measure	Time frame
Secondary end point(s): Response rate Safety Overall survival Response rate after cross over;Timepoint(s) of evaluation of this end point: 8 weeks During all study duration Until death 16 weeks	—

Countries

France

Contacts

Public ContactClinical trial information

IFCT

contact@ifct.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026