Iressa as Second Line Therapy in Advanced NSCLC-Asia (ISTANA)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

NSCLC

Treatments

Drug: Gefitinib

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00478049

D7913L00039

Details and patient eligibility

About

This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The total number of patients expected to be exposed to study procedures is approximately 150 patients will be recruited by investigational sites throughout the Asia Pacific region that have expertise in treating patients with NSCLC.

Enrollment

163 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma.
WHO Performance status 0-2
NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
Life expectancy of 12 weeks.

Exclusion criteria

ALT/AST: >2.5x ULRR if no demonstrable liver metastases or greater than 5 x ULRR in the presence of liver.
Inadequate bone marrow function; Absolute neutrophil count: <1.5 x 109/L, Platelets: < 100 x 109/L
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of skin or cervical cancer in situ