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A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer

Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00298688
Enrollment
56
Registered
2006-03-03
Start date
2004-09-30
Completion date
2007-03-31
Last updated
2008-06-12

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

Conditions

Small Cell Lung Cancer

Brief summary

The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib

Interventions

DRUGGefitinib

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Provision of written informed consent * Histologically confirmed, relapsed or refractory SCLCr * Aged 18 or over and a life expectancy of more than 2 months

Exclusion criteria

* Any evidence of clinically active interstitial lung disease * Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.

Design outcomes

Primary

MeasureTime frame
To determine the disease control rate in these patients

Secondary

MeasureTime frame
To determine the objective response rate at trail closure in these patients
To determine the time to progression-or-death in these patients
To determine overall survival in these patients

Countries

Denmark, United Kingdom

Outcome results

None listed

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