Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

Non Small Cell Lung Carcinoma Clinical Trial

Official title:

A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00234468
• Other study ID #: 1839IL/0126
• Status: Terminated
• Phase: Phase 3
• First received: October 5, 2005
• Last updated: May 19, 2011
• Start date: January 2004
• Est. completion date: August 2007

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 490
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Intervention

Drug:
• Iressa (Gefitinib)

Locations

Country	Name	City	State
Italy	Research Site	Avellino
Italy	Research Site	Bergamo
Italy	Research Site	Bologna
Italy	Research Site	Cagliari
Italy	Research Site	Campobasso
Italy	Research Site	Catania
Italy	Research Site	Catanzaro
Italy	Research Site	Chieti
Italy	Research Site	Cosenza
Italy	Research Site	Della Fratte
Italy	Research Site	Emilia
Italy	Research Site	Fano
Italy	Research Site	Firenze
Italy	Research Site	Forli
Italy	Research Site	Frattamaggiore
Italy	Research Site	Livorno
Italy	Research Site	Messina
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Novara
Italy	Research Site	Orbassano
Italy	Research Site	Padova
Italy	Research Site	Palermo
Italy	Research Site	Pavia
Italy	Research Site	Potenza
Italy	Research Site	Ravenna
Italy	Research Site	Rimini
Italy	Research Site	Roma
Italy	Research Site	San Giovanni Rotondo
Italy	Research Site	Sassari
Italy	Research Site	Taormina
Italy	Research Site	Venezia-Mestre

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression (2 years after Last patient in)
Secondary	Modalities of relapse or progression (2 years after Last patient in)
Secondary	Overall survival (2 years after Last patient in)