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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00091663
First received: September 15, 2004
Last updated: February 28, 2014
Last verified: February 2014

September 15, 2004
February 28, 2014
August 2004
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Complete list of historical versions of study NCT00091663 on ClinicalTrials.gov 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
Interventional
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5000
August 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00091663
OSI3199g
Not Provided
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