Advanced non small cell lung cancer (NSCLC) (Inoperable Stage III - IV). MedDRA version: 14.1 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: 14.1 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*1CPS 20MG
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: VINORELBINE DITARTRATE
CAS Number: 125317-39-7
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated IEC-approved informed consent. 2. Histologically or cytologically confirmed diagnosis of NSCLC. 3. Stage IV (using the 7th edition of AJCC, 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. 4. Patients with stable disease, according to RECIST 1.1, after four-six cycles of platinum-based chemotherapy as first line therapy. Patients who obtained partial or complete response during first line treatment must be excluded from the trial. 5. Patients who may have received adjuvant treatment (containing also vinorelbine) at least 6 months before study entry. 6. ECOG performance status 0-2. 7. Adequate bone marrow reserve as measured by ANC >/= 1500/mm3, hemoglobin >/= 9 g/dL, platelet count >/= 75,000 mcL, >/= 1 week after last transfusion of blood products and/or last dose of hematopoietic growth factor. 8. Prothrombin time (PT) or INR or aPTT 45 mL/min. 10. AST (SGOT) and ALT (SGPT) /= 18. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Patients who have received induction therapy with a platinum based chemotherapy doublet and achieved a Partial Response (PR) or a Complete Respose (CR) or a progressive disease (PD). 2. Patients who have received, or are scheduled to receive, single agent or combination therapy consisting of chemotherapy, targeted, biological, investigational, hormonal as maintenance treatment. 3. Patients who have received previous treatment for metastatic disease with chemotherapy containing oral or i.v. vinorelbine formulation. 4. Last dose of induction chemotherapy 42 days prior to randomization. 5. Concurrent treatment with other experimental drugs. 6. Radiation therapy within 3 weeks 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). 7. Major surgery within 4 weeks prior to first study drug administration. 8. Active central nervous system (CNS) metastatic disease. Patients with stable CNS disease following completion of radiation therapy and/or surgery are eligible. 9. Active or chronically recurrent bleeding (e.g., active peptic ulcer disease). 10. Malabsorption syndrome or any other disorder that would affect gastrointestinal absorption. 11. Clinically significant infection. 12. 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 months prior to first study drug administration, New York Heart Association Class II, III, or IV cardiovascular disease. 13. 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. 14. Past or current history of neoplasm other than curatively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix, unless that prior malignancy was diagnosed and definitely treated at least 3 years previously with no subsequent evidence of recurrence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of oral vinorelbine administered as a metronomic schedule in terms of Progression Free Survival (PFS) in advanced NSCLC patients with stable disease after first line platinum based chemotherapy.;Secondary Objective: 1. To assess the efficacy of oral metronomic vinorelbine in terms of OS, ORR and duration of response. 2. To assess the Time of Post Progression Survival. 3. To assess the Quality of Life. 4. To assess the safety profile.;Primary end point(s): Progression Free Survival (PFS): defined as the time from the date of randomization to the date of first documentation of progression, or of death due to any cause, whichever comes first.;Timepoint(s) of evaluation of this end point: At progression or at death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall Survival (OS): defined as the time from the date of randomization to the date of death from any cause or the last date the patient was known to be alive. 2. Objective Tumor Response Rate (ORR, CR+PR): defined as the proportion of patients with measurable disease at baseline achieving partial or complete overall best response according to RECIST version 1.1 criteria. 3. Duration of Response (only in patients in CR or PR): defined as the time from the date of the first documentation of confirmed objective tumor response to the date of first documentation of objective tumor progression, objective tumor recurrence, or of death due to progressive disease, whichever comes first. 4. Duration of Post Progression Survival: defined as the time from the date of first documentation of objective tumor progression to the date of death from any cause or the last date the patient was known to be alive. 5. Quality of Life (QoL) according to EORTC QLC30, EORTC QOL-LC13. 6. Overall Safety Profile, characterized by type, frequency, severity [graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0], timing and relationship to study therapy of adverse events and laboratory abnormalities.;Timepoint(s) of evaluation of this end point: 1. At death. 2. During all study period. 3. At progression or at recurrence or at death. 4. At death or at the last date the patient was known to be alive. 6. During all study period. 7. During treatmet. | — |
Countries
Italy
Contacts
Public ContactS.C. Medicina Oncologica 1
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed