A Study of Tarceva After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors - Full Text View

Sponsor:	OSI Pharmaceuticals
Collaborator:	Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00373425

Purpose

This is a study to evaluate the effectiveness of Tarceva (erlotinib) vs. placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Drug: Tarceva Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:

Disease Free Survival (DFS) [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up (up to 6 years) ] [ Designated as safety issue: No ]
DFS is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.

Secondary Outcome Measures:

Overall Survival (OS) [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (up to 10 years) ] [ Designated as safety issue: No ]
Survival will be defined as the time from the date of randomization until the documented date of death.
DFS in patients with EGFR mutation - positive tumors [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up (up to 6 years) ] [ Designated as safety issue: No ]
DFS is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.
OS in patients with EGFR mutation - positive tumors [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (up to 10 years) ] [ Designated as safety issue: No ]
Survival will be defined as the time from the date of randomization until the documented date of death.
Safety assessed through Adverse Events (AEs) and laboratory values [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (up to 10 years) ] [ Designated as safety issue: No ]

Enrollment:	1252
Study Start Date:	September 2006
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tarceva 150mg Daily	Drug: Tarceva 150mg Tablet Other Names: OSI-774 erlotinib
Placebo Comparator: Placebo Matching Placebo Daily	Drug: Placebo Placebo Tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary tissue from patient's surgery must be Epidermal growth factor receptor (EGFR)-positive by certain tests
Patients may have up to 4 cycles of chemotherapy after surgery
Complete removal of the tumor by surgery
Able to start drug under the following timelines:
- 6 months from the day of surgery for patients who get chemotherapy
- 3 months from the day of surgery for those who do not get chemotherapy
Confirmed diagnosis of Stage IB-IIIA NSCLC
Patients must be accessible for follow-up visits

Exclusion Criteria:

History of prior radiotherapy for NSCLC either before or after surgery
History of heart disease or uncontrolled heart arrhythmias within the previous year
History of poorly controlled Gastrointestinal (GI) disorders that could affect the absorption of study drug
History of other cancer except certain skin or cervical cancers, Patients who have had other cancer are eligible if they have remained disease free for at least 5 years
Patients who have received chemotherapy for NSCLC before surgery
Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373425

Show 293 Study Locations

Sponsors and Collaborators

OSI Pharmaceuticals

Astellas Pharma Global Development, Inc.

Investigators

Study Director:

Medical Monitor

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00373425 History of Changes
Other Study ID Numbers:	OSI-774-302, 2005-001747-29
Study First Received:	September 7, 2006
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Austria: Federal Office for Safety in Health Care; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Hungary: National Institute of Pharmacy; Italy: The Italian Medicines Agency; Korea: Food and Drug Administration; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: Ministry of Public Health; Russia: FSI Scientific Center of Expertise of Medical Application; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Taiwan: Center for Drug Evaluation; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by OSI Pharmaceuticals:

Adjuvant Non-small Cell Lung Cancer
Tarceva
Early-stage Lung Cancer
Adjuvant
RADIANT

NSCLC
EGFR-positive tumor
Stage IB Non-small Cell Lung Cancer
Stage II Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Lung Diseases
Respiratory Tract Diseases
Adjuvants, Immunologic
Erlotinib
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012