First line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological type MedDRA version: 14.1 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: Navelbine 20mg soft capsule
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Vinorelbine tartrate
CAS Number: 125317-39-7
Other descriptive name: VINORELBINE TARTRATE
Concentration
Sponsors
Pierre Fabre Medicament
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must satisfy all the following inclusion criteria before they are allowed to participate in the study: - patient must give written informed consent. - Chemo-naive patients superior or equal to 18 years - Performance status KPS superior or equal to 70% (ECOG/WHO PS 0-1) - Squamous histologically or cytologically (fine needle aspiration is acceptable) proven non-small cell lung cancer. - Stage IIIB (with supra-clavicular nodal metastases), stage IV or relapsing (locally or distant) after a local treatment. Patients not suitable for loco-regional treatment. - Life expectancy more than 12 weeks. - Adequate bone marrow, hepatic and renal functions: · Neutrophils superior or equal to 2.0x109/l, platelets superior or equal to 100x109/l, Haemoglobin superior or equal to 10 g/dl or 6.2 mmol/l. · Total bilirubin inferior or equal to 1.5xULN, Transaminases =65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: Patients with at least one of the following criteria will not be included: - Known hypersensitivity to the study drug(s) or to drugs with similar chemical structures. - Any important factor likely to modify drug absorption, e.g. surgery of gastro-intestinal tract, significant malabsorption syndrome or disease affecting the gastro-intestinal tract function. - Patients with a local relapse, which is liable to be treated by radiation therapy. - Previous radiotherapy in the only site used to assess response. - Radiotherapy within the previous 4 weeks. - Active central nervous system disorder, brain metastasis or leptomeningeal involvement. - Symptomatic neuropathy (sensory) superior or equal to grade 2 according to the NCI Common Toxicity Criteria (NCI ? CTC version 2). - Concomitant/uncontrolled medical disorder (superior cava vein syndrome, 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). - Weight loss > 10% within the previous 3 months. - Long term oxygen therapy. - Symptomatic ascite or pericardial effusion. - History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. - Concomitant treatment with another anticancer or any experimental drug within 30 days prior to the treatment period. - Women if pregnant or lactating or with positive pregnancy test at inclusion; woman of child-bearing potential who did not use or is unwilling or unable to use an acceptable method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, for the entire study period and for up to 3 months after the last dose of study treatment; - Sexually active fertile man not using effective birth control during the study and up to 3 months after the last dose of study treatment if his partner is a woman of child-bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the Disease Control Rate (CR, PR, SD in both arms) on the whole study period (combination and maintenance periods).;Secondary Objective: - Estimation of DCR at the end of combination period, - Estimation of Objective Response Rate on the whole study period, - Estimation of Objective Response Rate at the end of combination period, - Estimation of Duration of Disease Control, - Estimation of Duration of Response, - Estimation of Duration of Stable Disease, - Estimation of Progression-Free Survival, - Estimation of Time To Treatment Failure, - Estimation of Overall Survival. - Estimation of Tolerance. - Estimation of Quality of Life (LCSS questionnaire) - Estimation of Satisfaction Questionnaire.;Primary end point(s): Disease Control Rate (Tumour assessment);Timepoint(s) of evaluation of this end point: At baseline and every 6 weeks. After the completion of 4 cycles, in case of maintenance treatment, assessment will be performed every 6 weeks (2 cycles) until disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints will be assessed by tumour assessment. Safety will be assessed by: - Physical examination including vitals signs, body weight and performance status. - Complete blood cell count (WBC, Neutrophils, Haemoglobin and platelet counts). - Biochemistry. - Reporting adverse event using the NCI-CTC version 2.0 grading. - Quality of life questionnaire and satisfaction questionnaire.;Timepoint(s) of evaluation of this end point: Safety assessment will be performed at baseline, at each cycle, until end of study. Quality of life will be assessed at baseline, cycles 3 and 4, and end of study | — |
Countries
Austria, Brazil, Italy, Poland, Singapore, Spain, Taiwan
Contacts
Public ContactMarcello RIGGI
Pierre Fabre Medicament
Outcome results
None listed