A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144066

Enrollment

600

Registered

2005-09-02

Start date

2003-01-31

Completion date

Unknown

Last updated

2005-09-02

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

Conditions

Lung Cancer

Brief summary

A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV NSCLC.

Interventions

DRUGplatinum-based chemotherapy alone (up to six cycles)

DRUGplatinum-based chemotherapy followed by maintenance therapy with gefitinib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

Histologically or cytologically confirmed NSCLC Stage IIIB/IV No prior treatment Measurable disease ECOG PS 0-1 Adequate organ function Age 20-74 Written informed consent

Exclusion criteria

Pregnancy or breast feeding Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease

Design outcomes

Primary

Measure	Time frame
Over all survival	—

Secondary

Measure	Time frame
Time to disease progression	—

Outcome results

None listed

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