The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).

Official Title

A Randomized Placebo Controlled Study of OSI-744 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease


Non-Small-Cell Lung Carcinoma

Study Type


Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Study Start

October 2001; Study completion: January 2003

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria

  • Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.
  • Must have evidence of disease (clinical or radiological).
  • Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.
  • If the patient has had surgery, the surgery was at least 2 weeks ago.
  • Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms.
  • If the patient received radiation therapy, treatment was at least 4 weeks ago.

Total Enrolment


Contact Details

Australian Locations:Australian Capital Territory

  • Canberra Hospital- Australia, Woden, Australian Capital Territory, 2605, Australia

New South Wales

  • Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, 2289, Australia
  • Prince of Wales Hospital, Randwick, New South Wales, 2031, Australia
  • Southern Medical Day Care Center, Wollongong, New South Wales, 2500, Australia

South Australia

  • Royal Adelaide Hospital, South Australia, 5000, Australia


  • The Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia
  • Western Hospital, Footscray, Victoria, 3011, Australia
  • Austin & Repatriation Medical Centre, Victoria, 3084, Australia
  • Peter MacCallum Cancer Institute, Victoria, 3002, Australia

Western Australia

  • Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia

Contact OSI Pharmaceuticals

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