A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091663
Recruitment Status : Completed
First Posted : September 16, 2004
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):
Genentech, Inc.

September 15, 2004
September 16, 2004
March 4, 2014
August 2004
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Complete list of historical versions of study NCT00091663 on Archive Site
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A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer
This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.
Not Provided
Phase 3
Primary Purpose: Treatment
  • Lung Cancer
  • Non-small-cell Lung Carcinoma
Drug: Tarceva (erlotinib HCl)
Not Provided
Spigel DR, Lin M, O'Neill V, Hainsworth JD. Final survival and safety results from a multicenter, open-label, phase 3b trial of erlotinib in patients with advanced nonsmall cell lung cancer. Cancer. 2008 Jun 15;112(12):2749-55. doi: 10.1002/cncr.23490.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2005
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Inclusion Criteria:

  • Written (signed) informed consent(s)
  • Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC
  • Relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
  • Age >=18 years
  • ECOG performance status of 0 to 3
  • Recovered from the toxic effects of prior therapy
  • Able to comply with study and follow-up procedures
  • Able to take oral medication
  • Use of an effective means of contraception (for patients with reproductive potential)
  • Granulocyte count >=1.0 x 10^9/L
  • Platelet count >=75 x 10^9/L
  • Serum bilirubin <1.5 x upper limit of normal (ULN)
  • SGOT (AST) <2 x ULN unless elevation is clearly due to liver metastases; then SGOT (AST) must be <5 x ULN
  • Serum creatinine <=1.5 mg/dL

Exclusion Criteria:

  • Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
  • Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class
  • History of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of >=90%
  • Known central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
  • Nursing mothers or pregnant females
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Genentech, Inc.
Genentech, Inc.
Not Provided
Not Provided
Genentech, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP