previously untreated, EGFR + (FISH), advanced, non-squamous, NSCLC MedDRA version: 9.1 Level: HLGT Classification code 10029107
Conditions
Interventions
Trade Name: PANITUMUMAB
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PANITUMUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concent
Sponsors
SOUTHERN ITALY COOPERATIVE ONCOLOGY GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological diagnosis of previously untreated, non-squamous, NSCLC, EGFR + (FISH) - Stage IIIb or IV - Age 18-75 - PS ECOG 0-1 - At least 1 measurable lesion (RECIST v. 1.1) - Good main organs function - Written 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Past (within 5 years of study entry) or concurrent neoplasm other than adequately managed in situ carcinoma of the cervix and/or basal cell skin cancer - Clinically detectable brain metastases - Concurrent treatment with other chemotherapeutic, hormonal or biologic antineoplastic agents. - Prior exposure to cisplatin in the adjuvant setting - Previous chemotherapy for metastatic disease - Previous radiotherapy - Clinically significant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 6-MONTHS PROGRESSION FREE SURVIVAL RATE;Secondary Objective: • Overall Response Rate (ORR); • tolerability; • response duration (RD); • time to progression (TTP); • failure free survival (FFS); • progression free survival (PFS); • overall serviva (OS); • histologic type based subgroup analysis; • correlation between biomarkers(EGFR FISH, k-ras status, ERCC1, TS) and outcomes.;Primary end point(s): 6 mo PFSR has been chosen as a measure of activity of the treatment. It will be calculated from the date of enrolment to the date of progression of the disease including death from any cause, as the proportion of patients that will be still progression free at that time. | — |
Countries
Italy
Outcome results
None listed