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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: ZD6474
* Drug: Placebo
* Drug: ZD1839


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ZD6474|nan|
|Drug: Placebo|nan|
|Drug: ZD1839|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, locally advanced or metastatic, second-line