| A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone |
| A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib |
| This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Carcinoma, Non-Small Cell Lung |
- Drug: erlotinib
plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
- Drug: sunitinib
Sunitinib 37.5 mg daily by oral capsules in a continuous regimen
- Drug: placebo
Placebo daily by oral capsules in a continuous regimen
|
- Experimental: 1
Interventions:
- Drug: erlotinib
- Drug: sunitinib
- Active Comparator: 2
Interventions:
- Drug: erlotinib
- Drug: placebo
|
| Not Provided |
| |
| Completed |
| 960 |
| December 2012 |
| July 2010 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Patients with locally advanced/metastatic non-small cell lung cancer
- Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
Exclusion Criteria:
- Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
- History of or known brain metastases
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Germany, Greece, Hong Kong, Hungary, Italy, Korea, Republic of, Netherlands, Norway, Poland, Russian Federation, Slovakia, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States |
| |
| |
| NCT00457392 |
A6181087
SUN1087 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| September 2013 |
