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Klinische Studie für Patienten mit einer fortgeschrittenen Lungenkrebserkrankung mit zwei unterschiedlichen Behandlungsmethoden: Cisplatin oder Carboplatin mit Docetaxel in Kombination mit Cetuximab

Multizentrische, randomisierte Phase II-Studie zur Therapie des lokal fortgeschrittenen oder metastasierten NSCLC im Stadium IV UICC 7 mit zwei unterschiedlichen Regimen von Cisplatin / Carboplatin und Docetaxel in Kombination mit Cetuximab - TAX-ERB2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016806-18-DE
Enrollment
Unknown
Registered
2010-09-14
Start date
2010-12-09
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with advanced or metastatic NSCLC MedDRA version: 14.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Erbitux Product Name: Cetuximab Pharmaceutical Form: Solution for infusion Trade Name: Taxotere Product Name: Taxotere Pharmaceutical Form: Concentrate for solution for infusion Product

Sponsors

Klinik Löwenstein gGmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: rate of progressive free survival (PFS) after 24 weeks;Secondary Objective: - safety and toxicity - evaluation of quality of life - 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

MeasureTime frame
Secondary end point(s): 1. evaluation of quality of life 2. overall response rate (ORR) 3. progression free survival (PFS) 4. overall survival ;Timepoint(s) of evaluation of this end point: 1. at first cycle, after 12 and 24 weeks, thereafter every 3 months 2. every other cycle until progression 3. every other cycle until progression 4. every other cycle until progression—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026