Multizentrische randomisierte Phase II Studie zur Therapie des lokal fortgeschrittenen oder metastasierten NSCLC (Stadium IIIB/IV) mit Cisplatin/Docetaxel oder Oxaliplatin/Docetaxel A multicenter randomized phase II trial for the therapy of locally advanced or metastatic NSCLC (stage IIIB/IV) with cisplatin/docetaxel or oxaliplatin/docetaxel

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002197-35-DE

Enrollment

Registered

2008-06-13

Start date

2008-08-19

Completion date

Unknown

Last updated

2013-02-25

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

Conditions

locally advanced or metastatic NSCLC (stadium IIIB/ IV)

Interventions

Trade Name: Taxotere 80mg Konzentrat und Lösungsmittel zur Herstellung einer Infusionslösung Product Name: not applicable Product Code: not applicable Pharmaceutical Form: Concentrate for solution for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: histologically or cytologically confirmed NSCLC, stadium IIIB (curative treatment impossible) or IV. no prior cytostatic chemotherapy in metastatic state female and male patients aged >18 years ECOG = 2 Leukozytes > 3.000/µl Thrombozytes > 100.000/µl creatinine serum level = 1.25x ULN or Creatinine-Clearance > 45 ml/min parallel radiotherapy possible if target lesion not in radiation field written informed consent life expectancy > 3 months 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: Hypersensitivity for Cisplatin, Oxaliplatin or Docetaxel Neoadjuvant or adjuvant chemotherapy in the last 6 months radiotherapy in the last 28 days relevant systemic concomitant diseases Cardiomyopathy or heart insufficiency stadium II-IV according to NYHA second malignancy NCI grade II severe impairment of liver function (AST/ALT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN)participation in another clinical trial pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: response rate;Secondary Objective: safety and tolerability evaluation of quality of life progression free survival (PFS) time to treatment failure (TTF) overall survival;Primary end point(s): response rate	—

Countries

Germany

Outcome results

None listed

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