Study Stopped
Closed due to insufficient recruitment
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
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
1 other identifier
interventional
490
1 country
32
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2004
Typical duration for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 5, 2005
CompletedFirst Posted
Study publicly available on registry
October 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMay 20, 2011
May 1, 2011
October 5, 2005
May 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression (2 years after Last patient in)
Secondary Outcomes (2)
Modalities of relapse or progression (2 years after Last patient in)
Overall survival (2 years after Last patient in)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
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
Florence, Italy
Research Site
Forlì, Italy
Research Site
Frattamaggiore, Italy
Research Site
Livorno, Italy
Research Site
Messina, Italy
Research Site
Milan, Italy
Research Site
Napoli, Italy
Research Site
Novara, Italy
Research Site
Orbassano, Italy
Research Site
Padua, 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, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucio Crino, MD
Bologna Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 5, 2005
First Posted
October 7, 2005
Study Start
January 1, 2004
Study Completion
August 1, 2007
Last Updated
May 20, 2011
Record last verified: 2011-05