Iressa as Second Line Therapy in Advanced NSCLC-Asia

A Randomized, Open Label, Parallel Group, Regional, Multicenter, Phase III Study of Oral Gefitinib (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non Small Cell Lung Cancer Who Have Previously Received Platinum Based Chemotherapy (ISTANA)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00478049

Acronym

ISTANA

Enrollment

163

Registered

2007-05-24

Start date

2005-09-30

Completion date

2009-02-28

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Keywords

Non-Small Cell Lung Cancer

Brief summary

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.

Interventions

DRUGGefitinib

250 mg oral tablet

DRUGDocetaxel

intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors	Survival

Secondary

Measure	Time frame
To compare the overall objective tumor response rates between patients on gefitinib or on docetaxel by overall objective tumor response (complete response (CR) + partial response (PR)) using RECIST criteria.	Survival
To compare changes in quality of life (QoL) between patients on gefitinib or on docetaxel by QoL as measured by the FACT-L total score	Every Visit
For those patients who are symptomatic at baseline to compare improvement in symptom control between patients on gefitinib or on docetaxel by the FACT-L LCS (Functional Assessment of Cancer Therapy - Lung Lung Cancer Subscale).	Each Visit
To compare the safety and tolerability of gefitinib and of docetaxel by Frequency and severity of adverse events (AEs) and laboratory parameters.	Every Visit

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026