Phase 2 N=35 Randomized Treatment

Phase II Iressa & Carbo/Gem in NSCLC

Carcinoma, Non-Small-Cell Lung

Bottom Line

View on ClinicalTrials.gov: NCT00264498 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Progression Free Survival (PFS) — 131.0; 42.0 Days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Gefitinib (Drug); Gemcitabine (Drug); Carboplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: —

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression Free Survival (PFS)	131.0; 42.0	—

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.

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.

View full record on ClinicalTrials.gov →

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.