Patients with metastatic or locally advanced Non-small-cell lung cancer (NSCLC) MedDRA version: 20.0 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000015855 MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000015841
Conditions
Interventions
Trade Name: Navelbine
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VINORELBINE TARTRATE
CAS Number: 125317-39-7
Current Sponsor code: 220365-2017
Concentration unit: mg milligram(s)
Concent
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written (personally dated and signed) informed consent. 2. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and/or the follow-up schedule. 3. ECOG performance status 0-1 (also PS 2 after the first 6 patients if acceptable toxicity according to chapter 8: Toxicity and dose modifications. 4. Life expectancy = 10 weeks 5. Cytological or Histological confirmed squamous and non-squamous NSCLC in 1st or 2nd line where the investigator finds the patient suitable. 6. First line in stage IV NSCLC and in stage IIIB not suitable for curative treatment. Second line after immunotherapy (minimum 3 weeks after the last immunotherapy). 7. Presence of = 1 measurable lesion as per RECIST 1.1 which has not been previously irradiated. 8. Adequate bone marrow, hepatic and renal function as defined by the following laboratory values: •Absolute neutrophil count (ANC) = 1.5 x 109/L. •Platelet count = 100 x 109/L. •Haemoglobin = 10 g/dL or = 6.2 mmol/L. •Total serum bilirubin = 1.5 x ULN (= 3 x ULN in case of liver metastases). •Liver transaminases = 2.5 x ULN (= 5 x ULN in case of liver metastases). •Alkaline phosphatase = 5 x ULN. •Adequate renal function 9. Palliative radiotherapy can be allowed but not to the sites used for evaluation of response. (See section 4.4). 10. Fertile men should use effective contraceptive prevention. Fertile women must be using a medically accepted method of contraception to avoid pregnancy during 2 months preceding registration, throughout the study period and up to 3 months after last dose of study treatment in such a manner that the risk of pregnancy is minimized. Women who may be pregnant should have a pregnancy test. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Patients with NSCLC disease suitable for curable treatment. 2. No recovery to = G1 side effects (exception: alopecia) of any prior anti-neoplastic treatment. 3. Current peripheral neuropathy = G2. 4. Dysphagia or inability to swallow oral medication. 5. Malabsorption syndrome or disease significantly affecting GI-function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine. 6. Other serious illness or medical condition, such as but not limited to: a. Clinically significant cardiac disease or impaired cardiac function (such as: uncontrolled congestive heart failure requiring treatment; significant cardiac arrhythmia; conduction abnormality such as congenital long QT syndrome or high grade/complete AV-blockage; myocardial infarction within the previous 3 months, unstable angina pectoris, coronary artery bypass graft, coronary angioplasty or stenting, if 480 msec at screening) 7. Unstable diabetes mellitus. 8. Uncontrolled hypercalcemia. 9. Clinically significant active infections (current or within the last 2 weeks prior to registration). 10. Previous organ allograft. 11. Concomitant treatment with strong CYP3A4-inhibitors or strong CYP3A4-inducers (discontinuation before registration is acceptable, if medically feasible and ethically acceptable). 12. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: Evaluating the side effects (toxicity and feasibility, adverse events grade 2-5 (CTC)) during the first 84 days (12 weeks) of treatment. ;Secondary Objective: Secondary Objectives: Progression-free survival (PFS) The Disease Control Rate (CR + PR + SD, (SD > 4 months)). The duration of Disease Control Time to progression (TTP). The response rate (RR).;Primary end point(s): Metronomic chemotherapy is not yet well validated in the clinic, and we still need to identify the best medications and optimal dosage and regimens. By developing an effective oral treatment with frequent, daily doses of Navelbine Oral, we expect to achieve the same therapeutic benefit against the disease, as achieved by higher dose of Navelbine, twice in three weeks, but with less toxicity. ;Timepoint(s) of evaluation of this end point: The end of this trial will be reached at 4 months after last patient last treatment. There will be included 20 patients in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival (PFS) The Disease Control Rate (CR + PR + SD, (SD > 4 months)). The duration of Disease Control Time to progression (TTP). The response rate (RR).;Timepoint(s) of evaluation of this end point: The end of this trial will be reached at 4 months after last patient last treatment. There will be included 20 patients in this study. | — |
Countries
Denmark
Contacts
Public ContactClinical Research Unit (KFE)
Aarhus University Hospital (AUH)
Outcome results
None listed