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

Genzyme, a Sanofi Company160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ZD6474DRUG

PlaceboDRUG

ZD1839DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (48)

Outcomes

Primary Outcomes

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 Outcomes

Secondary Outcomes:

Part A

i. Objective response

ii. Disease control at 8 weeks

iii. Time to death

iv. WHO performance status

v. QOL and LCS from the FACT-L questionnaire

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

Data from ClinicalTrials.gov

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Research Site

Pine Bluff, Arkansas, United States

Research Site

Los Angeles, California, United States

Research Site

Palm Springs, California, United States

Research Site

San Diego, California, United States

Research Site

Boca Raton, Florida, United States

Research Site

Jacksonville, Florida, United States

Research Site

Orange Park, Florida, United States

Research Site

Coeur d'Alene, Idaho, United States

Research Site

Chicago, Illinois, United States

Research Site

Indianapolis, Indiana, United States

...and 38 more locations