Advanced Non Small Lung Cancer unfit for a platinium-based chemotherapy 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: Navelbine 20mg soft capsules
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VINORELBINE TARTRATE
CAS Number: 125317-39-7
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 equal to 18 years. -Histologically or cytologically confirmed NSCLC. -ECOG Performance Status of 0-1 or 2, -Advanced disease: 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. -Patients unfit for receiving a platinum-based chemotherapy based on at least one or more of the following criteria: . Previous adjuvant platinum-based chemotherapy for resected NSCLC; . Creatinine Clearance Grade 2; . Medical condition impairing platinum-based chemotherapy according to physician's opinion. -Life expectancy more than 12 weeks. -Adequate bone marrow, hepatic and renal functions: . Neutrophils > or equal 2.0 x 10(9)/l, Platelets > or equal 100 x 10(9)/l, Haemoglobin > or equal 10.0 g/dL; .Total bilirubin or equal 30 ml/min (Cockcroft and Gault formula), -Previous Therapy: .Chemotherapy: no previous chemotherapy for advanced NSCLC. Patients may have been treated with adjuvant chemotherapy for completely resected NSCLC; .Surgery: patients may have had previous surgery for NSCLC; .Radiation therapy: patient may have received prior radiotherapy but not on the site used to assess response. A minimum of 2 weeks interval must have elapsed; .Targeted therapy: patient with EGFR or ALK mutation may have had previous targeted therapy or immunotherapy. -Presence of at least one measurable lesion which has not been previously irradiated (RECIST Version 1.1). Measurable lesions (measured in at least one dimension, longest diameter to be recorded) as > or equal 20 mm with conventional techniques or as > or equal 10 mm with CT scan. 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 randomisation 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 oral vinorelbine 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 mus
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. -Any important factor likely to modify drug absorption (e.g. surgery of the gastro-intestinal tract, significant malabsorption syndrome or disease affecting the gastro-intestinal 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 brain metastases except for the followings: . Asymptomatic brain metastases which do not require local treatment in the opinion of the investigator; . Brain metastases for which local treatment has been given: at least 4 weeks off corticosteroids and/or anti-convulsants treatment before study randomisation. -Meningeal carcinomatosis. -Symptomatic neuropathy (sensory) > or equal grade 2 according to the NCI Common Toxicity Criteria (NCI - CTC version 4.0). -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, heart failure NYHA class III-IV, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment). -Symptomatic ascite or pericardial effusion. -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 oral vinorelbine. -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. -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 treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the Progression Free Survival (PFS) without Grade 4 toxicity (G4PFS) in both arms. This composite endpoint considers the first occurrence of either of the following: - Grade 4 toxicity (lower grade AEs are not considered), - Disease Progression or Death. ; Secondary Objective: In both arms: -To evaluate the Disease Control Rate without grade 4 toxicity, -To evaluate the Disease Control Rate, -To evaluate the Duration of Disease Control without grade 4 toxicity -To evaluate the Duration of Disease Control, -To evaluate the Objective Response Rate without grade 4 toxicity -To evaluate the Objective Response Rate, -To evaluate the Duration of Response, -To evaluate Time to first response, -To evaluate the Duration of Stable Disease, -To evaluate the Progression-Free Survival without Grade 2-3-4 toxicity, -To evaluate the Progression-Free Survival, -To evaluate the Time To Treatment Failure, -To evaluate the Overall Survival, -To evaluate the Tolerance, -To evaluate the Quality of Life. ;Primary end point(s): Progression Free Survival (PFS) without Grade 4 toxicity (G4PFS); 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. Safety will be assessed by: -Physical examination including vitals signs, body weight and performance status. -Complete blood cell count and serum biochemistry. -Reporting adverse event using the NCI-CTC version 4.0 grading. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -To evaluate the Disease Control Rate without grade 4 toxicity, -To evaluate the Disease Control Rate, -To evaluate the Duration of Disease Control without grade 4 toxicity -To evaluate the Duration of Disease Control, -To evaluate the Objective Response Rate without grade 4 toxicity -To evaluate the Objective Response Rate, -To evaluate the Duration of Response, -To evaluate Time to first response, -To evaluate the Duration of Stable Disease, -To evaluate the Progression-Free Survival without Grade 2-3-4 toxicity, -To evaluate the Progression-Free Survival, -To evaluate the Time To Treatment Failure, -To evaluate the Overall Survival, -To evaluate the Tolerance, -To evaluate the Quality of Life. ; 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. Safety will be assessed by: -Physical examination including vitals signs, body weight and performance status. -Complete blood cell count and serum biochemistry. -Reporting adverse event using the NCI-CTC version 4.0 grading. -Quality of Life Questionnaire (EORTC QLQ C30). | — |
Countries
Austria, Czech Republic, France, Germany, Greece, Hungary, Poland, Singapore, Spain
Contacts
Public ContactResponsable ensayos clínicos intern
PIERRE FABRE IBÉRICA, S.A.
Outcome results
None listed