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

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

This study is currently recruiting participants.
Verified by OSI Pharmaceuticals, September 2008

Sponsored by:	OSI Pharmaceuticals
Information provided by:	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

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

Erlotinib Erlotinib hydrochloride Epidermal Growth Factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	RADIANT: 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

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:

Disease Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	945
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 150 mg Tarceva Daily	Drug: Tarceva 150 mg
2: Placebo Comparator Placebo Tablet Daily	Drug: Placebo Placebo Tablet Daily

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 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 and 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 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 SCLC. Patients with carcinoid tumors are not eligible.

Contacts and Locations

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

Contacts


Contact: OSIP Medical Informaiton	800.572.1932, x7821	medical-information@osip.com

Contact: Tarceva Medical Information Direct	303-546-7821	medical-information@osip.com

Show 257 Study Locations

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

Responsible Party:	OSI Pharmaceuticals ( Karsten Witt, MD )
Study ID Numbers:	OSI-774-302
First Received:	September 7, 2006
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00373425
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Agency for Health and Food Safety; Belgium: Directorate general for the protection of Public health: Medicines; 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: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Pharmacological Committee, Ministry of Health; South Korea: Korea Food and Drug Administration (KFDA); Spain: Spanish Agency of Medicines; Taiwan: Department of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:

Adjuvant Non-small Cell Lung Cancer

Lung Cancer

Early-stage Lung Cancer

Adjuvant

RADIANT

NSCLC

Tarceva

EGFR-positive tumor

Stage IB Non-small Cell Lung Cancer

Stage II Non-small Cell Lung Cancer

Stage IIIA Non-small Cell Lung Cancer

Study placed in the following topic categories:

Erlotinib

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008