Phase II Iressa & Carbo/Gem in NSCLC
A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2
1 other identifier
interventional
38
1 country
1
Brief Summary
The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 12, 2005
CompletedFirst Posted
Study publicly available on registry
December 13, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
August 3, 2009
CompletedAugust 3, 2009
June 1, 2009
December 12, 2005
June 11, 2009
June 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression
Date of randomization to earliest date of objective disease progression
Study Arms (2)
1
ACTIVE COMPARATORGemcitabine + Carboplatin
2
EXPERIMENTALGefitinib
Interventions
Eligibility Criteria
You may qualify if:
- Advanced Non Small cell Lung Cell Lung cancer
- Never received chemotherapy
- Up and about 50% of waking hours
You may not qualify if:
- Spread of lung cancer to the brain
- Low level of white blood cells
- Radiotherapy within 4 weeks
- Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No analysis of the efficacy results was performed as the study was prematurely terminated with only 35 out of the planned 122 subjects randomized. Serious and Other adverse event data for Periods 1 and 2 were combined by treatment for this report.
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Canada Oncology Medical Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 12, 2005
First Posted
December 13, 2005
Study Start
October 1, 2004
Study Completion
June 1, 2008
Last Updated
August 3, 2009
Results First Posted
August 3, 2009
Record last verified: 2009-06