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).Estudio abierto, aleatorizado, multinacional en fase IIIb para evaluar la actividad y seguridad de cetuximab como tratamiento de mantenimiento a 250 mg/m2 una vez por semana y 500 mg/m2 cada dos semanas después de la quimioterapia a base de platino en combinación con cetuximab como tratamiento de elección en pacientes con cáncer de pulmón no microcítico (CPNM). - NEXT
- Conditions
- on-Small Cell Lung Cancer.Cancer de pulmon n o microcíticoMedDRA version: 9.1Level: LLTClassification code 10066490Term: Progression of non small cell lung cancer
- Registration Number
- EUCTR2008-004454-33-ES
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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 and no more than 300 mg/m² cisplatin was administered
? 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