Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
NSCLC, locally advanced or metastatic, second-line
Brief summary
The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor * Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC
Exclusion criteria
* Subjects who have received second-line or subsequent chemotherapy * Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes: | — |
| Part A | — |
| i. Time to progression | — |
| ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes | — |
| Part B | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Objective response | — |
| ii. Disease control at 8 weeks | — |
| iii. Time to death | — |
| ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment | — |
| v. QOL and LCS from the FACT-L questionnaire | — |
| Part B | — |
| i. Objective response in subjects following treatment with the alternate study treatment | — |
| iv. WHO performance status | — |
| iii. WHO performance status in subjects following treatment with the alternate study treatment | — |
| iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment | — |
| Secondary Outcomes: | — |
| Part A | — |
Countries
Argentina, Belgium, Germany, South Africa, United Kingdom, United States
Outcome results
None listed