Clinical trial · Interventional
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
NCT00264498CI-TRIAL-00002506completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Gemcitabine + Carboplatin
- interventionNames
- Drug: Gemcitabine
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- 2
- description
- Gefitinib
- interventionNames
- Drug: Gefitinib
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Date of randomization to earliest date of objective disease progression
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.