RADIANT: A Study of Tarceva After Surgery With or Without Adjuvant Chemotherapy in NSCLC Patients Who Have EGFR-positive Tumors - Full Text View

RADIANT: A Study of Tarceva After Surgery With or Without Adjuvant Chemotherapy in NSCLC Patients Who Have EGFR-positive Tumors (Adjuvent)

This study is currently recruiting participants.

Verified by OSI Pharmaceuticals, September 2009

First Received: September 7, 2006 Last Updated: November 3, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

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 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	945
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 150mg Tarceva Daily	Drug: Tarceva 150mg
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 Information	800.572.1932	medical-information@osip.com
Contact: Tarceva Medical Information Direct	303.546.7821	medical-information@osip.com

Show 270 Study Locations

Sponsors and Collaborators

OSI Pharmaceuticals

Investigators

Study Director:

Julie Horan

OSI Pharmaceuticals

More Information

No publications provided

Responsible Party:	OSI Pharmaceuticals ( Angela Davies, MD )
Study ID Numbers:	OSI-774-302
Study First Received:	September 7, 2006
Last Updated:	November 3, 2009
ClinicalTrials.gov Identifier:	NCT00373425 History of Changes
Health Authority:	United States: Food and Drug Administration

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:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Protein Kinase Inhibitors

Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009