Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Signed and dated approved ICF
Histologically or cytologically confirmed diagnosis NSCLC diagnosis
Stage IV (using AJCC 7th edition, or wet IIIb / IV using the 6th edition), or recurrent locally advanced disease not amenable to radiation or surgery with curative intent and not amenable to concurrent chemoradiation
Patients with stable disease, after four-six cycles of platinum-based chemotherapy as first line therapy. Patients with partial or complete response during first line chemotherapy according to RECIST criteria can be enrolled provided that they have stable disease at the study entry.
Patients who may have received adjuvant treatment (containing also vinorelbine) at least 6 mos before study entry
ECOG performance status 0-2
Adequate bone marrow reserve as measured by ANC ≥ 1500/mm3, hemoglobin ≥ 9 g/dL, platelet count ≥ 100,000/μL, ≥ 1 week after last transfusion of blood products and/or last dose of hematopoietic growth factor
Prothrombin time (PT) or INR or aPTT ≤ 1.5 x ULN
Calculated creatinine clearance ≥ 30 mL/min (Cockcroft and Gault Formula)
AST (SGOT) and ALT (SGPT) < 2.5 x ULN, AST and ALT < 5 x ULN (if documented liver metastases)
Serum bilirubin < 2.0 mg/dL (patients with Gilbert's syndrome: serum bilirubin ≤ 3 x ULN
Alkaline phosphatase < 2.5 x ULN (patients with documented liver or bone metastases, alkaline phosphatase ≤ 5 x ULN)
No other obvious related major organ toxicities which would compromise the patient's ability to participate in a clinical trial
Allowed prior radiation therapy for local or locally advanced disease providing that any clinically significant adverse effects associated with prior therapy have recovered to Grade 1 or less
Women of childbearing potential must have a negative serum pregnancy test and agree to use effective birth control during the trial and for 12 wks after the last treatment dose
Males must agree to use effective birth control for themselves or their partner during the trial and for 12 wks after the last treatment dose
Life expectancy of at least 12 wks
Male or female, age ≥18

Exclusion Criteria:

Patients who have received induction therapy with platinum obtaining progressive disease
Patients who can benefit from pemetrexed maintenance treatment (adenocarcinoma and ECOG PS 0-1) should be excluded. Enrollment in the trial is permitted for patients who refuse maintenance with pemetrexed or in case of clinical contraindications to pemetrexed therapy (for example renal failure, creatinine clearance ≤ 45 mL/min)
Patients who have received, or are scheduled to receive, single agent or combination therapy consisting of chemotherapy, targeted, biological, investigational, hormonal as maintenance treatment
Previous treatment for metastatic disease with chemotherapy containing oral or i.v. vinorelbine formulation
Last dose of induction chemotherapy < 21 d prior to randomization or > 42 d prior to randomization
Concurrent treatment with other experimental drugs.
Radiation therapy within 3 wks prior to randomization (palliative radiation therapy is allowed, provided that sites of bone marrow production, i.e., iliac crests are not in the radiation field)
Major surgery within 4 wks prior to first study drug administration
Active central nervous system (CNS) metastatic disease. Patients with stable CNS disease following completion of radiation therapy and/or surgery are eligible
Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
Malabsorption syndrome or any other disorder affecting gastrointestinal absorption
Clinically significant infection
Clinically significant cardiovascular disease or condition including: congestive heart failure (CHF) requiring therapy, need for anti-arrhythmic therapy for a ventricular arrhythmia, severe conduction disturbance, angina pectoris requiring therapy, medically uncontrolled hypertension per the Investigator's discretion, myocardial infarction within 6 mos prior to first study drug administration, New York Heart Association Class II, III, or IV cardiovascular disease
Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator
History of neoplasm other than curatively treated non-melanoma skin cancer or other carcinoma in situ, that has been resected, unless that prior malignancy was diagnosed and definitely treated at least 3 ys previously with no subsequent evidence of recurrence