Entry Detail
| General information | |
| Database: | DB00771 |
| Objective: | Sunitinib malate (SUTENT) has promising singleagent activity given on Schedule 4/2 (4 weeks on treatment follotheyd by 2 weeks off treatment) in advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Novello S, et al |
| Title: | Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non small cell lung cancer. |
| Journal: | Br J Cancer. |
| Year: | 2009 |
| PMID: | 19826424 |
| 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: | Phase II study |
| Key Patients Feature: | Patients > or =18 years with stage IIIB/IV non small cell lung cancer after failure with platinumbased chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received sunitinib 37.5 mg per day |
| Primary End Point: | objective response rate (ORR) |
| Secondary End Point: | progression free survival (PFS), overall survival (OS), 1year survival rate, and safety. |
| Patients Number: | 47 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 2.1% (95% confidence interval (CI) 0.1, 11.3) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.9 weeks (95% CI 8.6, 14.1) |
| Median OS A vs. C: | 37.1 weeks (95% CI 31.1, 69.7). The 1year survival probability was 38.4% (95% CI 24.2, 52.5). |
| Adverse Event(agent arm): | The most commonly reported AEs (all causality) were generally mildtomoderate (grade 1/2) in severity |
| Conclusions: | The safety profile and timetoevent analyses, albeit relatively low response rate of 2%, suggest singleagent sunitinib on a CDD schedule may be a potential therapeutic agent for patients with advanced, refractory non small cell lung cancer. |