Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy

Genzyme

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Erlotinib; Drug: Vandetanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00364351

D4200C00057

EUDRACT No. 2006-000259-16

Details and patient eligibility

About

To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib

Enrollment: 1,574 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed locally advanced or metastatic NSCLC
• Failure of at least one but not more than two prior chemotherapy regimens

Exclusion criteria

• Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent), sorafenib (Nexavar)
• Chemotherapy or other type of anti cancer therapy within 4 weeks of study start

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,574 participants in 2 patient groups

1

Active Comparator group

Description:

Erlotinib

Treatment:

Drug: Erlotinib

2

Experimental group

Description:

Vandetanib

Treatment:

Drug: Vandetanib