Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00242801

Enrollment

1692

Registered

2005-10-21

Start date

2003-07-31

Completion date

2005-04-30

Last updated

2009-04-23

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

Conditions

NSCLC

Brief summary

This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.

Interventions

DRUGGefitinib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* · Life expectancy of at least 8 weeks. * 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 * Not suitable for chemotherapy * WHO Performance status 0,1, 2 or 3

Exclusion criteria

* Newly diagnosed CNS mets * Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity * ALT/AST greater than 5 x upper limit of normal * ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care	—

Secondary

Measure	Time frame
· ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure	—
· ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall	—
· objective tumour response (CR + PR)	—
· ZD1839 + BSC versus Placebo + BSC in terms of tolerability	—
· ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes	—

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Estonia, Germany, Greece, Hungary, India, Ireland, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Venezuela

Outcome results

None listed

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