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

Completed · Phase 3

Conditions studied: Lung Cancer, Non-small-cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT00091663

Run by

Genentech, Inc.

People needed

5000

Starts

2004-08-01

Expected to finish

2005-08-01

Last updated by the study team

2014-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Cancer and Blood Institute Medical Group — Rancho Mirage, California, United States
• Los Palos Oncology and Hematology Center — Salinas, California, United States
• Naveen Gupta, MD, Inc. — Upland, California, United States
• Hematology Oncology, PC — Stamford, Connecticut, United States
• Lee Cancer Clinic — Fort Myers, Florida, United States
• Florida Wellcare Alliance — Inverness, Florida, United States
• Florida Oncology Associates — Jacksonville, Florida, United States
• Osceola Cancer Center — Kissimmee, Florida, United States
• Florida Cancer Institute — New Port Richey, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Mid-Florida Hematology & Oncology Centers, P.A. — Orange City, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Metcare Oncology — Ormond Beach, Florida, United States
• Hematology Oncology Associates — Pensacola, Florida, United States
• Oncology and Hematology Associates of West Broward P.A. — Tamarac, Florida, United States
• Comprehensive Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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