Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer

A Phase II Study to Evaluate the Efficacy and Safety of Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00173875

Enrollment

108

Registered

2005-09-15

Start date

2005-03-31

Completion date

2007-07-31

Last updated

2007-07-30

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

Conditions

Non-Small Cell Lung Cancer

Keywords

EGFR Non-small cell lung cancer

Brief summary

The purpose of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)

Detailed description

The epidermal growth factor receptor (EGFR) is a promising target for anticancer therapy because it is expressed or highly expressed in a variety of tumors, including NSCLC.Furthermore, high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies. EGFR-targeted cancer therapies are currently being developed; strategies include inhibition of the intracellular tyrosine kinase domain of the receptor by small molecules such as gefitinib (Iressa \[ZD1839\]; AstraZeneca, Wilmington, DE). Iressa is an orally active, selective EGFR tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells.

Interventions

DRUGIressa

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically or cytologically confirmed stage IIIB/IV NSCLC * No immediate need for palliative radiotherapy and No prior chemotherapy * age \> 20 Y/O * ECOG PS: 0 - 2 * ANC \>2000 * PLT \>100k * Hb \> 10 * total bilirubin \< 2.0 mg/dL * serum creatinine \< 2 mg/dl * SGPT and SGOT \< 2.5 ×ULN, alkaline phosphatase \< 5 ×ULN * life expectancy \>6mos.

Exclusion criteria

* If the patients have brain metastases or receive radiotherapy, the disease must be stable for more than 6 weeks after the last dose of radiotherapy * 2nd malignancies * Unable to swallow tablets * Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements * Pregnant or lactating patients * Participation in other clinical trials within 30 days of study entry * Major systemic disease which in the investigator's opinion might confound the clinical trial

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer	2005~2007

Secondary

Measure	Time frame
To evaluate 1) Individual response rate 2) Time to progression 3) Overall survival (OS) at year1 4) Progression free survival (PFS) at year1 5) Toxicity	2005~2007

Countries

Taiwan

Outcome results

None listed

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