Open, randomized, multinational phase IIIb trial evaluating the activity and safety of cetuximab as 250 mg/m² weekly and 500 mg/m² every two weeks maintenance therapy after platinum-based chemotherapy in combination with cetuximab as first-line treatment for subjects with advanced non-small cell lung cancer (NSCLC) - NEXT
- Registration Number
- EUCTR2008-004454-33-NL
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method