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 (RADIANT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00373425
First received: September 7, 2006
Last updated: January 6, 2014
Last verified: January 2014
  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 3

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:


Further study details as provided by Astellas Pharma Inc:

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), laboratory values, physical examinations and Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ 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
Primary Completion Date: April 2013 (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 295 Study Locations
Sponsors and Collaborators
OSI Pharmaceuticals
Investigators
Study Director: Medical Monitor Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( 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 6, 2014
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 Astellas Pharma Inc:
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
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014