Klinische Studie für Patienten mit einer fortgeschrittenen Lungenkrebserkrankung mit zwei unterschiedlichen Behandlungsmethoden: Cisplatin oder Carboplatin mit Docetaxel in Kombination mit Cetuximab
- Conditions
- patients with advanced or metastatic NSCLCTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 14.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2009-016806-18-DE
- Lead Sponsor
- Klinik Löwenstein gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- histologically or cytologically confirmed NSCLC stadium IV UICC 7
- life expectance more than 3 month
- ECOG performance status 0 or 1
- positiv EGFR status (IHC score =200)
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
Exclusion Criteria
- systemic chemotherapy within the last 6 months before screening
- radiotherapy within the last 28 days before screening
- known CNS-metastasis
- any prior or existing malignancies except for basal squamous cell skin cancer and adequately treated carcinoma in situ of the cervix
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: rate of progressive free survival (PFS) after 24 weeks;Secondary Objective: - safety and toxicity<br>- evaluation of quality of life<br>- tumor response, progressive free survial, overall survival time;Primary end point(s): rate of progression free survival after 24 weeks;Timepoint(s) of evaluation of this end point: 24 weeks after start of therapy, staging evaluation every other cycle
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. evaluation of quality of life<br>2. overall response rate (ORR)<br>3. progression free survival (PFS)<br>4. overall survival ;Timepoint(s) of evaluation of this end point: 1. at first cycle, after 12 and 24 weeks, thereafter every 3 months<br>2. every other cycle until progression<br>3. every other cycle until progression<br>4. every other cycle until progression<br>