Patients with advanced or metastatic non-small cell lung cancer (NSCLC) MedDRA version: 9.1 Level: LLT Classification code 10066490 Term: Progression of non small cell lung cancer
Conditions
Interventions
Trade Name: Erbitux®
Product Name: Cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Other descriptive name: IgG1 monoclonal antibody
Concentration unit: mg/ml millig
Sponsors
Klinik Löwenstein gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histologically or cytologically confirmed inoperable non-small cell lung cancer stage IIIb or IV - No previous chemotherapy or EGFR therapy for this advanced or metastatic disease - Patients with a measurable disease, e.g. at least one measurable lesion which will be detected with clinical-radiological procedures (x-ray,CT) according to RECIST 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: - Any prior or existing malignancies except NSCLC. Except for basal or squamous cell skin cancer and adequately treated carcinoma in situ of the cervix - Chemotherapy for the metastatic NSCLC - Application of any other chemotherapy during trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Tumour response according to RECIST;Secondary Objective: Toxicity; 1 year survival; Median overall survival; Progress free survival ;Primary end point(s): Objective response (tumour response according to RECIST) | — |
Countries
Germany
Outcome results
None listed