Phase 2
Completed N=35
Phase II Iressa & Carbo/Gem in NSCLC
Source: ClinicalTrials.gov NCT00264498 ↗Enrolled (actual)
35
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Progression Free Survival (PFS) — 131.0; 42.0 Days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
131.0; 42.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00264498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.