| September 7, 2006 |
| November 3, 2009 |
| September 2006 |
| September 2009 (final data collection date for primary outcome measure) |
| Disease Free Survival [ Time Frame: 3 Months ] [ Designated as safety issue: No ] |
| Disease Free Survival [ Time Frame: 7 years ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00373425 on ClinicalTrials.gov Archive Site |
- Overall Survival [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
|
| Safety, Overall Survival [ Time Frame: 7 years ] [ Designated as safety issue: Yes ] |
| |
| RADIANT: A Study of Tarceva After Surgery With or Without Adjuvant Chemotherapy in NSCLC Patients Who Have EGFR-positive Tumors |
| 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 |
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 |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Non-small Cell Lung Cancer |
- Drug: Tarceva
- Drug: Placebo
|
- Placebo Comparator: 150mg Tarceva Daily
- Placebo Comparator: Placebo Tablet Daily
|
| |
| |
| Recruiting |
| 945 |
| September 2013 |
| September 2009 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
|
|
| United States, Argentina, Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom |
| |
| NCT00373425 |
| Angela Davies, MD, OSI Pharmaceuticals |
| OSI-774-302 |
| OSI Pharmaceuticals |
|
| Study Director: |
Julie Horan |
OSI Pharmaceuticals |
|
|
| OSI Pharmaceuticals |
| September 2009 |
