Patients with: -Histologically or cytologically confirmed NSCLC (stage IIIB or IV) and -epidermal growth factor receptor (EGFR) positive mutation and -previously treated with tyrosine kinase inhibitor (gefitinib or erlotinib) MedDRA version: 14.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms be
Conditions
Interventions
Trade Name: Navelbine® oral 20mg
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
CAS Number: 125317-39-7
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Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient must give written (personally signed and dated) informed consent before completing any study-related procedure. - Patients > or = 18 years. - Histologically or cytologically confirmed NSCLC. - Patients with epidermal growth factor receptor (EGFR) positive mutation. - Patients progressing or relapsing after treatment with EGFR tyrosine kinase inhibitors but a minimum of 2 weeks must have elapsed prior to start of study treatment. - Performance status KPS > or = 70% (ECOG/WHO PS 0-1). - Stage IIIB (with supra-clavicular nodal metastases), stage IV. - Life expectancy more than 12 weeks. - Adequate bone marrow, hepatic and renal functions: Neutrophils > or = 2.0 x 10^9/l, Platelets > or = 100 x 10^9/l, Haemoglobin > or = 10.0 g/dL; Total bilirubin or = 40 ml/min (Cockcroft and Gault formula). - Prior therapy: Chemotherapy: patient must not have had systemic chemotherapy or immunotherapy (monoclonal antibody); Radiation therapy: patient is eligible if presence of target lesions outside the irradiated area. A minimum of 4 weeks must have elapsed prior to start of study treatment. - Presence of at least one measurable lesion (measured in at least one dimension) which has not been previously irradiated (RECIST criteria – version 1.1). Physical examination and ultrasound will not be considered as objective tumour assessments. - Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial. - Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment. - Fertile men must be using an effective method of birth control if their partners are women of childbearing potential throughout the study period and for up to 3 months after the last dose of study treatment. - The patient must have access to social insurance according to local regulations. 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: Patients with at least one of the following criteria will not be included: - Known hypersensitivity to the study drug or to drugs with similar chemical structures. - Participation in another clinical trial with any experimental drug within the 30 days before registration and/or during the study. - Any important factor likely to modify drug absorption (e.g. surgery of the gastrointestinal tract, significant malabsorption syndrome or disease affecting the gastrointestinal tract function). - Previous radiotherapy in the only site used to assess response. - Clinically relevant or unstable systemic disease making implementation of the protocol difficult. - Active central nervous system disorder, brain metastasis or leptomeningeal involvement. - Symptomatic neuropathy (sensory) > or = grade 2 according to the NCI Common Toxicity Criteria (NCI – CTC version 2). - Weight loss > 10% within the previous 3 months. - Long term oxygen therapy. - Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment). - Women if pregnant or lactating or with positive pregnancy test at inclusion; - Women of childbearing potential who did not use or is unwilling or unable to use an acceptable method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment. - Sexually active fertile men not using effective method of birth control method throughout the study period and for up to 3 months after the last dose of study treatment if his partner is a woman of childbearing potential. - Other malignancies except adequately treated basal carcinoma of the skin, in-situ cervix carcinoma or any other tumor with a disease free interval > 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the disease control rate (CR, PR, SD) of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor ; Secondary Objective: To evaluate efficacy and safety parameters : The Duration of Disease Control, The Objective Response Rate and Duration of Response, The Time to First Response, Duration of Stable Disease, The Progression-Free Survival (PFS), Time To Treatment Failure (TTF), The Overall Survival (OS), The tolerance in the setting of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor. ; Primary end point(s): To evaluate the disease control rate (CR, PR, SD) of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor ;Timepoint(s) of evaluation of this end point: Tumour assessment will be performed according to the RECIST guideline (version 1.1). Assessment of measurable disease will be carried out at baseline and every 6 weeks until disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate efficacy and safety parameters - the response rate. - the duration of the disease control, the duration of response, the Time to Treatment Failure (TTF). - the Progression Free Survival (PFS) and Overall Survival (OS). - the tolerance in this setting of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor. ;Timepoint(s) of evaluation of this end point: every 6 weeks | — |
Countries
Argentina, Austria, Poland, Singapore, Taiwan
Contacts
Public ContactMarcello RIGGI
PIERRE FABRE MEDICAMENT
Outcome results
None listed