The purpose of this study is to determine whether nintedanib (vargatef®) combined with docetaxel are effective in second line of treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy.
59 Patients with histologically documented stage IV NSCLC no squamous, after failure of first line chemotherapy and refractory (progressive disease during first line chemotherapy), will be enroled to receive docetaxel :75 mg/m² IV day 1 every 3 weeks with nintedanib (vargatef®):200 mg X 2/day per os day2-day21. Tumor response (according to RECIST) will be assessed via computed tomography or magnetic resonance imaging scan every 6 weeks (evaluation of PFS) following completion of chemotherapy. Adverse events (AEs) were graded according to the National Cancer Institute Common Toxicity Criteria, version 4.0 Quality of life(EQ5-D ) will be assessed every 6 weeks during chemotherapy. Tolerability will be assessed at each visit based on Common Terminology Criteria for Adverse Events (CTCAE), v4.0 criteria. Total study duration per patient: approximately 12 months .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
CH de Beauvais
Beauvais, France
CHU Brest
Brest, France
Service de Pneumologie
Créteil, France
Service de Pneumologie
Gap, France
median progression free survival
Time frame: 12 weeks
median progression free survival
Time frame: 12 month
Toxicity (NCIC-CTC version 4.0 criteria)
Time frame: Every 3 weeks during treatment up to 12 months from inclusion
Quality of life (EQ5-D questionnaire)
Time frame: every 6 weeks up to 12 months from inlcusion
Response rate
Time frame: 12 month
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CHU de Limoges
Limoges, France
CH de Bretagne Sud
Lorient, France
Centre Hospitalier F. Quesnay
Mantes-la-Jolie, France
AP-HM
Marseille, France
Institut Paoli-Calmettes
Marseille, France
Instiut de Cancérologie
Saint-Etienne, France
...and 1 more locations