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


Tracking Information

Start Date  ICMJESeptember 2006
Estimated Primary Completion DateSeptember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2009)		Disease Free Survival [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: January 16, 2008)		Disease Free Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00373425 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 5, 2009)
  • Overall Survival [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: January 16, 2008)		Safety, Overall Survival [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title  ICMJERADIANT: A Study of Tarceva After Surgery With or Without Adjuvant Chemotherapy in Non-small Cell Lung Carcinoma (NSCLC) Patients Who Have EGFR-positive Tumors
Official Title  ICMJERADIANT: 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
Brief Summary

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

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJENon-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Tarceva
    150mg
  • Drug: Placebo
    Placebo Tablet Daily
Study Arms / Comparison Groups
  • 1: Placebo Comparator
    150mg Tarceva Daily
    Intervention: Drug: Tarceva
  • 2: Placebo Comparator
    Placebo Tablet Daily
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE945
Estimated Completion DateSeptember 2013
Estimated Primary Completion DateSeptember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: OSIP Medical Information800.572.1932medical-information@osip.com
Contact: Tarceva Medical Information Direct303.546.7821medical-information@osip.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Spain,   Taiwan,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00373425
Responsible PartyAngela Davies, OSI Pharmaceuticals
Study ID Numbers  ICMJEOSI-774-302
Study Sponsor  ICMJEOSI Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Julie HoranOSI Pharmaceuticals
Information Provided ByOSI Pharmaceuticals