Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00001485

Trial Description

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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

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Trial Acronym

RADIANT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00001485
  •   2012/10/19
  •   2006/09/07
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Secondary IDs

  •   2005-001747-29 
  •   NCT00373425  (clinicaltrials.gov)
  •   OSI-774-302  (OSI Pharmaceuticals)
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Health Condition or Problem studied

  •   Non-small Cell Lung Cancer
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Drug: Tarceva
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- 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); 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.

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Secondary Outcome

- 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); 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); 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); 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)

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Italy
  •   Korea, Republic of
  •   Poland
  •   Romania
  •   Russian Federation
  •   Spain
  •   Taiwan, Province of China
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2006/09/30
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  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • OSI Pharmaceuticals
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    • Astellas Pharma Global Development
    • Medical Monitor 
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    • Astellas Pharma Global Development
    • Medical Monitor 
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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2013/10/20
* This entry means the parameter is not applicable or has not been set.