metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type MedDRA version: 20.0 Level: LLT Classification code 10064049 Term: Lung adenocarcinoma metastatic System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ZADAXIN - 1.6 MG/ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 1 ML
Product Name: ZADAXIN
Pharmaceutical Form: Po
Sponsors
SCICLONE PHARMACEUTICALS ITALY S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 years or older; Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples will be enrolled; Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy ; Measurable disease by Response Evaluation Criteria In Solid Tumours (RECIST) in a lesion not previously irradiated or non-measurable disease; Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2; Absolute neutrophil count (ANC) > 1.5 x 10 9 /liter (L) and platelets > 100 x 10 9 /L ; Bilirubin level either normal or =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Prior therapy with Thymosin alpha-1; Prior therapy with a study drug ; Newly diagnosed central nervous system (CNS) metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (SD) (no steroid therapy or steroid dose being tapered) for at least 28 days; Pregnancy or suspected pregnancy; Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study; Known severe hypersensitivity to a study drug or anyof the excipients of this product; Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ; Any evidence of clinically active interstitial lung disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangiticcarcinomatosis need not be excluded); As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease); As judged by the investigator, any inflammatory changes of the surface of the eye; Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity/efficacy in terms of PFS of SoC chemotherapy with cisplatin (or carboplatin) and either Pemetrexed, Paclitaxel, Gemcitabine, or Bevacizumab+Thymosin alpha 1 in patients with advanced EGFR wild type NSCLC as compared to a control group of patients receiving SoC chemotherapy alone. ; Secondary Objective: Overall Survival (OS); Quality of Life (QoL); Organ failure free days; Safety; Biomarkers of immunity and inflammation. ;Primary end point(s): Time to PSF;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to Overall Survival (OS);Timepoint(s) of evaluation of this end point: Approximately at 26 months follow up | — |
Countries
Italy
Contacts
Public ContactProcuratore Speciale
Sciclone Pharmaceuticals Italy Srl
Outcome results
None listed