Third-line treatment in patients with non-small cell lung cancer (NSCLC) patients with EGFR-mutated or unknown MedDRA version: 16.1 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: 16.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl c
Conditions
Interventions
Trade Name: GEMCITABINA
Product Name: GEMCITABINA
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: mg
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histological or cytological diagnosis of NSCLC in stage IIIB -IV, according to the 7th TNM . • State of EGFR - mutated or unknown . • Patients who have received two prior lines of chemotherapy for advanced disease, the last of which ended at least three weeks. They are also eligible patients who have already received, in addition to 2 lines of chemotherapy; more than 1 line of treatment different from chemotherapy provided no EGFR inhibitors (see exclusion criterion 1). • Written informed consent. • Age = 18 years. • Performance Status (PS ) = 2 of the ECOG scale . • Life expectancy of at least 12 weeks. • Is permitted radiotherapy with palliative intent before starting treatment. • X-ray examination should be used as a baseline evaluation was performed within 28 days of the start of chemotherapy. • Baseline hematological examinations performed within 7 days prior to enrollment , with the following values : hemoglobin = 9 g / dl , = 1.500/mm3 neutrophils , platelets = 100.000/mm3 , total bilirubin = 1.5 times the upper limit of normal , ALT , AST = 2 times the upper limit of normal , creatinine within the normal range. • When it comes to women of childbearing age, the patient should make use of appropriate means of contraception. 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 238 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: • Patients who have received prior EGFR inhibitors. • Patients who have previously received gemcitabine (in case of non-squamous histology) or vinorelbine (in the case of squamous histology). * (See section 7.3) • Patients with brain metastases are not controlled. • Patients who are currently treated with experimental agents or who have interrupted a clinical study of not less than 30 days. • Patients who have ongoing infections or uncontrolled diabetes mellitus or heart disease grade III-IV NYHA or other serious disease .. • Patients with cancer with ALK rearrangement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of chemotherapy (gemcitabine or vinorelbine with respect of histology) compared to erlotinib in the treatment of patients with advanced NSCLC, EGFR wild-type or unknown in progression after 2 lines of chemotherapy;Secondary Objective: To describe the effect of a therapy with gemcitabine or vinorelbine (with respect of histology) compared to erlotinib in the treatment of patients with advanced NSCLC, EGFR wild-type or unknown in progression after two lines of chemotherapy in terms of: a) quality of life b) safety, c) cost for the Regional Health Service, d) anti-tumor activity.;Primary end point(s): The primary endpoint of the trial is overall survival (OS), calculated as the time interval from the registration / randomization to death from any cause . The periods of observation of patients not yet become deceased at the time of the analysis of the results will be truncated at the date of their last status information in life.;Timepoint(s) of evaluation of this end point: 8-9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of the study are: 1 . Improving the quality of life is defined as the percentage of patients who have had an increase in quality of life (defined in accordance with specific questionnaires LCSS score and EQ -5D employees) from baseline to follow-up visits compared with patients who did not have increases or worsening of quality of life. 2 . Haematological and non-haematological toxicity incidence as defined in each individual patient adverse events of grade 3 or 4 , as measured by NCI - CTCAE version 4.03 and occurred during the entire period of treatment provided by the therapeutic protocol . 3 . Evaluation of direct medical costs (medication, hospitalization, treatment adverse events) and indirect costs (lost work days and reduced productivity caused by the disease by patients and caregivers). 4 . Disease control rate as a percentage of patients who will be observed a complete or partial response or stable disease defined according to RECIST version 1.1 5 . PFS ( PFS ) defined as the time interval from randomization to the occurrence of the first of the following two events , disease progression or death from any cause The periods of observation of patients who do not become yet progressed or died at the time of the analysis of results will be truncated at the date of their last status information in life. ;Timepoint(s) of evaluation of this end point: 8-9 weels | — |
Countries
Italy
Contacts
Public ContactUOC ONCOLOGIA MEDICA
AZIENDA OSPEDALIERO UNIVERSITARIA DI PARMA
Outcome results
None listed