Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
Interventions
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV) * Failure of first-line platinum-based chemotherapy
Exclusion criteria
* Mixed small cell or non-small-cell histology * Bronchoalveolar carcinoma * Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin) * Prior treatment with docetaxel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL and lung cancer subscale (LCS) from the FACT-L questionnaire | — |
| WHO performance status | — |
| Time to death | — |
| Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes; | — |
| Objective response rate and duration of response | — |
Countries
Czechia, Hungary, United States
Outcome results
None listed