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Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00234468
Enrollment
490
Registered
2005-10-07
Start date
2004-01-31
Completion date
2007-08-31
Last updated
2011-05-20

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

Conditions

Non Small Cell Lung Carcinoma

Keywords

Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)

Brief summary

The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy

Interventions

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

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

Inclusion criteria

* Histologically Confirmed Non Small Cell Lung Cancer. * Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy). * Chemotherapy with regimens containing cisplatin or carboplatin is mandatory * Response to combined therapy

Exclusion criteria

* No previous treatment with ZD1839 or any other EGFR-targeted therapy * No progressive disease after combined therapy for locally advanced NSCLC * No presence of metastatic disease * No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * Any unresolved chronic toxicity from previous anticancer therapy.

Design outcomes

Primary

MeasureTime frame
Time to progression (2 years after Last patient in)

Secondary

MeasureTime frame
Modalities of relapse or progression (2 years after Last patient in)
Overall survival (2 years after Last patient in)

Countries

Italy

Outcome results

None listed

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