Phase II Iressa & Carbo/Gem in NSCLC

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Gemcitabine; Drug: Gefitinib; Drug: Carboplatin

• Registration Number: NCT00264498
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-13
• Study Completion: 2008-06
• Status Verified: 2009-06
• Results First Submitted: 2009-06-11
• Results First Submitted QC: 2009-06-11
• Last Update Submitted: 2009-06-11
• Results First Posted: 2009-08-03
• Last Update Posted: 2009-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Advanced Non Small cell Lung Cell Lung cancer
• Never received chemotherapy
• Up and about 50% of waking hours

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gemcitabine	Gemcitabine + Carboplatin
1	Carboplatin	Gemcitabine + Carboplatin
2	Gefitinib	Gefitinib

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Date of randomization to earliest date of objective disease progression	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

Trial Locations

Locations (1)

Research Site; 🇨🇦 Montreal, Quebec, Canada