Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Non Small Cell Lung Carcinoma

Treatments: Drug: Iressa (Gefitinib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234468

1839IL/0126

Details and patient eligibility

About

The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy

Enrollment: 490 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically Confirmed Non Small Cell Lung Cancer.
• Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
• Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
• Response to combined therapy

Exclusion criteria

• No previous treatment with ZD1839 or any other EGFR-targeted therapy
• No progressive disease after combined therapy for locally advanced NSCLC
• No presence of metastatic disease
• No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Any unresolved chronic toxicity from previous anticancer therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind