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A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC


Phase 2
70 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma

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Trial Information

A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC


Inclusion Criteria:



- Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue

- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable
to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks

- WHO Performance status <= 2

Exclusion Criteria:

- Newly diagnosed CNS metastases

- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy
related toxicity.

- Hypersensitivity to ZD1839 or intravenous vinorelbine

- Prior treatment with EGFR inhibitors

- Other co-existing malignancies

- ALT/AST >2.5 x ULRR

- ANC < 2.0 x 10^9/L or platelets < 100 x 10^9/L

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare ZD1839 and vinorelbine in terms of progression free survival

Principal Investigator

AstraZeneca Iressa Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Czech Republic: State Institute for Drug Control

Study ID:

D791AC00001

NCT ID:

NCT00256711

Start Date:

July 2004

Completion Date:

February 2006

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Locally advanced or metastatic NSCLC.
  • Stage IIIb or Stage IV lung cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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