This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT00059722
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2003-05-02
• Study First Submitted QC: 2003-05-02
• Study First Posted: 2003-05-05
• Study Completion: 2007-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
i. Objective response
iv. WHO performance status
Part A
Part B
i. Objective response in subjects following treatment with the alternate study treatment
ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
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
iii. Time to death
Secondary Outcomes:
ii. Disease control at 8 weeks
v. QOL and LCS from the FACT-L questionnaire

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom