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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Time to progression (2 years after Last patient in)

Principal Investigator

Lucio Crino, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bologna Italy

Authority:

Italy: Ministry of Health

Study ID:

1839IL/0126

NCT ID:

NCT00234468

Start Date:

January 2004

Completion Date:

August 2007

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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