Phase 3
Completed N=960
A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
Source: ClinicalTrials.gov NCT00457392 ↗Enrolled (actual)
960
Serious AEs
40.8%
Results posted
Aug 2011
Primary outcomePrimary: Overall Survival (OS) — 9.0; 8.5 Months — p=0.1933
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
9.0; 8.5 | 0.1933 |
| SECONDARY Progression-Free Survival (PFS) |
15.5; 8.7 | 0.0023 sig |
| SECONDARY Percentage of Participants With Objective Response (OR) |
10.60; 6.90 | 0.0471 sig |
| SECONDARY Duration of Response (DR) |
39.6; 32.3 | — |
| SECONDARY One-year Survival Probability |
40.0; 37.0 | — |
| SECONDARY EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score |
0.750; 0.716; 0.615; 0.598 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00457392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.