None listed
Conditions
Interventions
Trade Name: Erbitux 5mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 5-
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria (for details see section 5.3.1): • Subject has given written informed consents before any trial-related activities are carried out • Male or female, =18 years of age at the time of informed consent, inpatient or outpatient • Adequate renal, hepatic and bone marrow function • Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIB NSCLC with pleural effusion or stage IV • Presence of at least 1 uni-dimensionally measurable index lesion, whereby index lesions must not lie in a previously irradiated area • ECOG performance status of 0 or 1 at inclusion in the trial • Effective contraception for male and female subjects, if risk of conception exists 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: Main exclusion criteria (for details see section 5.3.2): • Previous exposure to EGFR-targeting therapy (not monoclonal antibodies in general or signal transduction inhibitors, which would be allowed) • Previous chemotherapy for NSCLC; neo-adjuvant or adjuvant (radio-)chemotherapy is allowed if it was finished 6 months prior to start of trial treatment • Major surgery within 30 days prior to inclusion in the trial • Prior chest irradiation within 90 days prior to inclusion in the trial (palliative radiation of bone lesions is allowed) • Participation in another clinical trial or treatment with any investigational agent(s) within 30 days prior to inclusion in the trial • Documented or symptomatic brain metastasis • Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix • Cardiovascular or neurological impairment or infection that prevent the use of trial treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Separate assessment of the activity of each cetuximab maintenance therapy (500 mg/m² every 2 weeks and 250 mg/m² every week) in terms of overall survival time from inclusion in the trial to death in subjects with advanced NSCLC who are free of progression after having received cetuximab in combination with a platinum doublet chemotherapy as first-line treatment.;Secondary Objective: comprise the evaluation of activity in the maintenance therapy period and in the overall study period in terms of overall survival time (maintenance therapy phase only), time to treatment failure, unconfirmed tumor response and disease control, the evaluation of activity in Caucasian subjects and the comparison of the two maintenance therapy regimens. The safety of cetuximab in combination with platinumbased chemo-therapy and as single agent maintenance therapy when administered at doses of 250 mg/m² weekly or 500 mg/m² every 2 weeks will be evaluated;Primary end point(s): Overall survival time defined as time from inclusion into the trial to death. | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Slovakia, Spain, United Kingdom
Outcome results
None listed