Patients with Inoperable (Stage III/IV) Non-Small Cell Lung Cancer Of Non-Squamous Type not previously treated with chemotherapy related to the current disease
Conditions
Interventions
Product Name: Nanoplatin
Pharmaceutical Form: Solution for infusion
Sponsors
Regulon AE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male or female;18-75 years of age; histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC of other than predominantly squamous cell histology; at least one unidimentionally measurable lesion; no prior chemotherapy/other investigational drug treatment for current disease; performance status 0-1; life expectancy >3 months; adequate haematologic/hepatic/renal function; signed informed consent. 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 284
Exclusion criteria
Exclusion criteria: o Squamous or undifferentiated NSCLC. o Eligibility for other curative intent treatment (e.g. surgery). o Other malignancy within the past 5 years, except malignancies with 25% weight loss). o Recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, congenital heart disease, or ventricular arrhythmias. o History of Hepatitis B or C (HBs Ag or anti-HCV). o HIV seropositivity. o Known underlying immune deficiency or history of autoimmune diseases. o Pregnant or lactating women. For women of childbearing age an initial negative pregnancy test and usage of a reliable contraceptive method during and for 3 months after study participation is a requirement. o Any medical, psychiatric or social condition that would preclude informed consent (e.g. homeless patients or with dementia). o Patients for whom compliance with the protocol is doubtful
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficiency and safety between the two arms of treatment. The primary objective of the study is to compare Progression-Free Survival (PFS) between the Nanoplatin-pemetrexed (Arm A) and cisplatin-pemetrexed (Arm B) NSCLC patients;Secondary Objective: • To compare overall survival (OS) • To compare overall response rate (ORR) • To compare duration of response • To compare quality of life • To compare the toxicity profiles ;Primary end point(s): Progression-Free Survival (PFS);Timepoint(s) of evaluation of this end point: Evaluation of response after 3rd and 6th cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): overall survival (OS) overall response rate (ORR) duration of response quality of life toxicity profiles ;Timepoint(s) of evaluation of this end point: Evaluation of response after 3rd and 6th cycle. | — |
Countries
China, France, Germany, Greece, Israel, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, Turkey
Contacts
Public Contacthttp://clintest.org/admin/support
Regulon AE
Outcome results
None listed