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CompletedPhase 3NCT00036647
Official study title

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

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTarceva (erlotinib HCl, OSI-774 )

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 10, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?97 U.S. locations

Locations may change over time.

Who runs it?OSI Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
OSI Pharmaceuticals
Interventions being studied
Drug: Tarceva (erlotinib HCl, OSI-774 )
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
EGFR→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Chicago Medical CenterChicago, Illinois
  • University of WashingtonSeattle, Washington
  • Centro Medico ConfidenceBuenos Aires, CP
  • Hospital BritanicoBuenos Aires
  • Hospital Interzonal de Agudos EvitaBuenos Aires
  • Instituto Alexander flemingBuenos Aires
  • Hospital Churruca ViscaBuenos Aires
  • Instituto Oncologico Angel RoffoCapital Federal
  • Hospital ItalianoCapital Federal
  • Canberra Hospital- AustraliaWoden, Australian Capital Territory
  • Prince of Wales HospitalRandwick, New South Wales
  • Newcastle Mater Misericordiae HospitalWaratah, New South Wales

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 10, 2018. Always confirm current availability with the study team.

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