Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study | NCT00242801

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 Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Apr 2005Actual

First Submitted Date

Oct 19, 2005

First Submission Date that Met QC Criteria

Oct 20, 2005

First Posted Date

Oct 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2009

Last Update Posted Date

Apr 23, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,692

Name	Type	Description	Arm Group Labels	Other Names
Gefitinib	Drug

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca Oncology Medical Science Direction	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Capital Federal	Buenos Aires		Argentina
Research Site

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds