CompletedPhase 3

OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

United States, Argentina731 participantsStarted 2001-11-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

Trial details

NCT IDNCT00036647

SponsorOSI Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-01-30

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