Entry Detail
| General information | |
| Database: | DB00772 |
| Objective: | Aberrant vascular endothelial growth factor (VEGF) and plateletderived growth factor (PDGF) signaling have been shown to play a role in non small cell lung cancer (non small cell lung cancer) pathogenesis and are associated with decreased survival. they evaluated the clinical activity and tolerability of sunitinib malate (SU11248), an oral, multitargeted tyrosine kinase inhibitor that blocks the activity of receptors for VEGF and PDGF, as well as related tyrosine kinases in patients with previously treated, advanced non small cell lung cancer. |
| Authors: | Socinski MA, et al |
| Title: | Multicenter, phase II trial of sunitinib in previously treated, advanced non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2008 |
| PMID: | 18235126 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Multicenter, phase II trial |
| Key Patients Feature: | Patients with stage IIIB or IV non small cell lung cancer for whom platinumbased chemotherapy had failed |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received 50 mg/d of sunitinib for 4 weeks follotheyd by 2 weeks of no treatment in 6week treatment cycles. |
| Primary End Point: | objective response rate (ORR); |
| Secondary End Point: | progression free survival, overall survival, and safety. |
| Patients Number: | 63 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 11.1% (95% CI, 4.6% to 21.6%) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 12.0 weeks (95% CI, 10.0 to 16.1 weeks) |
| Median OS A vs. C: | 23.4 weeks (95% CI, 17.0 to 28.3 weeks) |
| Adverse Event(agent arm): | NA |
| Conclusions: | Sunitinib has promising singleagent activity in patients with recurrent non small cell lung cancer, with an ORR similar to that of currently approved agents and an acceptable safety profile. Further evaluation in combination with other targeted agents and chemotherapy in patients with non small cell lung cancer is warranted. |