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

Phase 1

• Conditions: on squamous non small cell lung cancer of advanced stage; MedDRA version: 14.1Level: LLTClassification code 10025062Term: Lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004524-38-FR
• Lead Sponsor: IFCT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-21
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Progression free survival;Secondary Objective: Response rate<br>Overall survival<br>Safety<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Response rate<br>Safety<br>Overall survival<br>Response rate after cross over;Timepoint(s) of evaluation of this end point: 8 weeks<br>During all study duration<br>Until death<br>16 weeks