Histologically/cytologically confirmed diagnosis of metastatic NSCLC. Possibility to obtain tumor tissue form primary tumor or from an accessible metastatic site, or possibility to collect any neoplastic effusion. Performance status of 0-1 according to ECOG score.
Conditions
Interventions
Trade Name: CARBOPLATINO TEVA IV 10F 10MG
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CARBOPLATIN
CAS Number: 41575-94-4
Current Sponsor code: NA
Other descriptive
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically/cytologically confirmed diagnosis of metastatic NSCLC. Possibility to obtain tumor tissue form primary tumor or from an accessible metastatic site, or possibility to collect any neoplastic effusion. Performance status of 0-1 according to ECOG score. At least one measurable lesion according to RECIST criteria. At least one previous standard chemotherapy regimen and previous therapy with an EGFR-TKI if EGFR mutated or crizotinib (or other anti ALK agent) if ALK positive. Adequate hematological, renal and liver functions. Radiological evidence of disease progression to the last anticancer therapy. At least 21 days since the last chemotherapy or any anticancer dose. No concomitant comorbidity potentially interfering with the study. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method (intrauterine contraceptive device (IUD), birth control pills, or barrier device) during and for three months after trial 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: No possibility to obtain tumor tissue or neoplastic effusion. Performance status >1 according to ECOG score. No measurable lesion(s) Life expectancy less than 3 months. Important comorbidity interfering with the study. Significant alteration of liver, hematological or renal function(s). Brain metastases. Patients with resected brain metastases, or with asimptomatic brain metastases already treated with radiotherapy are eligible if they not need for steroids or antiepilettic drugs.No informed consent form signature
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary end-points: Response rate (RR) in pretreated metastatic NSCLC Identification of the minimal in vitro CSC mortality rate translating in a clinical response according to RECIST criteria. ;Secondary Objective: Secondary end-point: Progression-free survival (PFS) Overall Survival (OS) Toxicity Biomarkers associate with drug sensitivity ;Primary end point(s): Primary end-points: Response rate (RR) in pretreated metastatic NSCLC Identification of the minimal in vitro CSC mortality rate translating in a clinical response according to RECIST criteria;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-point: Progression-free survival (PFS) Overall Survival (OS) Toxicity Biomarkers associate with drug sensitivity ;Timepoint(s) of evaluation of this end point: two years | — |
Countries
Italy
Outcome results
None listed