NSCLC (Non-small Cell Lung Cancer) stage IIIB/IV MedDRA version: 13.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Navelbine 20 mg
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VINORELBINE DITARTRATE
Current Sponsor code: Vinorelbine
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – Age >= 18 years – Histologically or cytologically (fine needle aspiration) proven NSCLC – First line treatment of NSCLC (no prior chemotherapy or radiotherapy for the treatment of NSCLC) is indicated – NSCLC stage IIIB or stage IV or recurrence after local therapy – At least one measurable lesion (RECIST) of NSCLC – Karnofsky Performance Status >= 70% – Life expectancy >= 12 weeks – Adequate bone marrow, hepatic and renal function: • Neutrophils >= 2.0 x 109/l • Platelets >= 100 x 109/l • Haemoglobin >= 12 g/dl • Total bilirubin = 65 ml/min) – Written informed consent (including consent to data reporting) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: – Symptomatic neuropathy (sensory) > grade 1 according to CTCAE – CNS metastases – Concomitant / uncontrolled medical disorder (ischaemic heart disease, cardiac failure or myocardial infarction within the previous 3 months; uncontrolled hypertension or arrhythmia; hypotension; active infection requiring intravenous antibiotics within 2 weeks prior to enrollment; uncontrolled hypercalcaemia) – Superior vena cava syndrome – History of other malignancy except carcinoma in situ of the cervix or appropriately treated skin basal cell cancer. Patients with a history of cancer and at least 5 years of uneventful follow-up without treatment and no signs of recurrence may be eligible. – Concomitant or previous treatment of NSCLC with other anticancer drugs or radiotherapy – Previous treatment with vinorelbine – Concomitant treatment with vasodilating drugs (e.g., calcium channel blockers or nitroglycerin [other than study medication]) – Known hypersensitivity or contra-indications to study medication (vinorelbine, cisplatin or nitroglycerin) or drugs with similar chemical structures as the study medications – Concomitant treatment with corticosteroids except chronic treatment lasting more than 1 month at low doses (<= 20 mg/day of methylprednisolone or equivalent) – Significant malabsorption syndrome or disease affecting the gastrointestinal tract function and the absorption of oral drugs – Pregnant or breast-feeding women – Male or female patients with reproductive potential must use an approved contraceptive method during and for 6 months after the end of treatment with study medication – Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to study screening – Incapability to give valid informed consent (including patients who are dependent on the sponsor or the investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of overall response rates (ORR) in the 2 treatment arms;Secondary Objective: Comparison of the 2 treatment arms with regard to - time to progression (TTP) - overall survival (OS) - toxicity profile;Primary end point(s): Overall response rates according to RECIST in all randomized patients having received at least one dose of study medication unless the patient was lost to follow-up immediately after the start of treatment | — |
Countries
Germany
Outcome results
None listed