No squamous non small cell lung MedDRA version: 18.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Vergatef
Pharmaceutical Form: Capsule
CAS Number: 656247-17-5
Other descriptive name: NINTEDANIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
T
Sponsors
CHU de Limoges
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed non-squamous NSCLC, • Locally advanced and/or metastatic NSCLC of stage IV (according to American Joint Committee on Cancers) or recurrent NSCLC) • Patients without activating EGFR mutation • Patients without ALK rearrangement • Patients must have measurable lesion by RECIST 1.1 • Refractory disease defined by documented progression during the first-line chemotherapy based on a platinum doublet and third-generation drug (four or less cycles) according to RECIST V.1.1 • Age =18 years and grade I (except alopecia). • Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin 1.5 G/l, platelets > 100 G/l). • Anticoagulation with a vitamin K antagonist and LMWH is authorized. • Antiplatelet treatment (aspirin authorized if =65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: Known hypersensitivity to the trial drugs (nintedanib, docetaxel), to their excipients or to contrast media • Controlled disease after first line treatment • Contra indication to the use of the backbone treatment • Patients who were withdrawn from first line treatment due to toxicity without documented disease progression or who received placebo (in the context of a clinical trial) as prior treatment are not eligible. • Previous treatment with docetaxel • Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer. • Previous therapy with VEGF inhibitors except bevacizumab • Centrally located tumour with radiographic evidence of local invasion of local blood vessels • Radiographic evidence of cavitary or necrotic tumours at screening • Chemo-, hormono-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug. • Radiotherapy (except extremities) within the past 3 months prior to baseline imaging • Persistence of clinically relevant therapy related toxicity from previous radiotherapy • Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before inclusion). • Uncontrolled arterial hypertension. • Concurrent radiotherapy, except for palliative bone irradiation. • Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction less than 12 months before study entry). • Stroke less than 6 months before study entry. • Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial • Grade ?1 peripheral neuropathy • Uncontrolled infection. • Caval syndrome • Other organic disorders preventing inclusion in the trial • Malabsorption syndrome • Pregnancy and breast-feeding • Surgery less than two months before study entry. • Follow-up not feasible. • Incarcerated and institutionalized
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of the the nintedanib- docetaxel combination in second-line treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy;Secondary Objective: - To assess toxicities and feasibility -To evaluate tolerability during treatment - To assess overall survival, overall response rate, and quality of life - To assess progression free survival in patients according to disease progression at 2 or 4 cycles of first line treatment ;Primary end point(s): Median progression free survival at 12 weeks ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To assess toxicities and feasibility - To evaluate tolerability during treatment - To assess overall survival, overall response rate, and quality of life - To assess progression free survival in patients according to disease progression at 2 or 4 cycles of first line treatment. ;Timepoint(s) of evaluation of this end point: To evaluate tolerability during treatment: every 3 weeks - To assess overall survival, overall response rate: at 12 month -To assess and quality of life:every 6 weeks - To assess progression free survival in patients according to disease progression at 2 or 4 cycles of first line treatment. ach cycle | — |
Countries
France
Contacts
Public ContactClinical Trials Information
Centre Hospitalier de Mantes La Jolie
Outcome results
None listed