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

Phase 3

Completed

• Conditions: Non-small-cell Lung Carcinoma; Lung Cancer

• Registration Number: NCT00091663
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-09-15
• Study First Submitted QC: 2004-09-15
• Study First Posted: 2004-09-16
• Study Completion: 2005-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (92)

Comprehensive Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

Hematology-Oncology Specialist, Center for Cancer Care; 🇺🇸 Huntsville, Alabama, United States

Providence Alaska Medical Center; 🇺🇸 Anchorage, Alaska, United States

Palo Verde Hematology/Oncology, Ltd.; 🇺🇸 Glendale, Arizona, United States

Arizona Hematology Oncology, PC; 🇺🇸 Tucson, Arizona, United States

Little Rock Hematology Oncology Associates; 🇺🇸 Little Rock, Arkansas, United States

Tower Hematology Oncology Medical Group; 🇺🇸 Beverly Hills, California, United States

Southbay Oncology Hematology Partners; 🇺🇸 Campbell, California, United States

Antelope Valley Cancer Center; 🇺🇸 Lancaster, California, United States

Clinical Trials and Research Associates, Inc.; 🇺🇸 Montebello, California, United States

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