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A Study With Tarceva and Chemotherapy vs. Chemotherapy Alone in Patients With Advanced Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: October 16, 2002
Last updated: June 19, 2013
Last verified: June 2013
The purpose of this study is to determine if Tarceva plus standard chemotherapy is more effective than standard chemotherapy alone in the treatment of lung cancer.

Condition Intervention Phase
Lung Cancer
Drug: Tarceva (erlotinib HCl)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double Blind, Multicenter Trial of Tarceva (Erlotinib) Plus Chemotherapy (Carboplatin and Paclitaxel) Versus Chemotherapy Alone in Patients With Advanced (Stage IIIb or IV) Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Study Start Date: July 2001
Study Completion Date: July 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • Age >=18 years
  • Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
  • A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
  • Measurable or non-measurable disease
  • ECOG performance status of 0 or 1
  • Life expectancy of >=3 months
  • >= 3 weeks since any prior surgery or radiotherapy (>=2 weeks for patients who receive <=30 Gy of radiotherapy involving <25% of the marrow reserve)
  • Use of an effective means of contraception (women of childbearing potential)
  • Able to comply with study and follow-up procedures

Exclusion Criteria:

  • Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
  • Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
  • Symptomatic or untreated brain metastases
  • Prior systemic chemotherapy for NSCLC
  • Prior exposure to agents directed at the HER axis (e.g., ZD1839 [Iressa], C225 [Cetuximab], Trastuzumab [Herceptin])
  • Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible)
  • History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
  • Pregnancy or lactation

Any of the following abnormal baseline hematologic values:

  • Granulocytes count <=1500/uL
  • Platelet count <100,000/uL

Any of the following abnormal baseline liver function tests:

  • Serum bilirubin >1.5× upper limit of normal (ULN)
  • Serum ALT and AST >=2.5× ULN (>5× ULN if due to liver metastases)
  • Alkaline phosphatase >=2.5× ULN

Other baseline laboratory values:

  • Serum creatinine >1.5× ULN or creatinine clearance <60 mL/min
  • Uncontrolled hypercalcemia (>11.5 mg/dL)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00047736

United States, Colorado
Multinational Sites
Denver, Colorado, United States
Trial Information Center
Denver, Colorado, United States
Sponsors and Collaborators
Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT00047736     History of Changes
Obsolete Identifiers: NCT00029016
Other Study ID Numbers: OSI2298g
Study First Received: October 16, 2002
Last Updated: June 19, 2013

Keywords provided by Genentech, Inc.:
Non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017