Entry Detail
| General information | |
| Database: | DB00082 |
| Objective: | to assess the efficacy and toxicity of sorafenib as frontline therapy in patients with stage IIIB (pleural effusion) or IV non small cell lung cancer |
| Authors: | Dy GK, et al |
| Title: | A frontline window of opportunityphase 2 study of sorafenib in patients with advanced nonsmall cell lung cancer: North Central Cancer Treatment Group Study N0326. |
| Journal: | cancer |
| Year: | 2010 |
| PMID: | 21218460 |
| Trial Design | |
| Clinical Trial Id: | North Central Cancer Treatment Group Study N0326 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| 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: | A IIstagephase II study based on a Fleming design |
| Key Patients Feature: | Patients with histologic or cytologic evidence of measurable metastatic or stage IIIB (with malignant pleural effusion) non small cell lung cancer with no prior chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received sorafenib 400 mg twice daily by mouth continuously, and were evaluated every 2 weeks during the first 8 weeks. Patients who manifested clinical progression during this period proceeded to receive standard of care. |
| Primary End Point: | confirmed objective tumor response. |
| Secondary End Point: | NA |
| Patients Number: | 25 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | 2.8months (95% CI, 1.84.6 months) |
| Median PFS A vs. C: | 2.8 months; Seven (28%) patients remained progression free at 24 weeks. |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | No grade 3 or higher hematologic adverse events were observed. Thirteen (52%) patients had a grade 3 nonhematologic adverse event, with fatigue (20%), diarrhea (8%), and dyspnea (8%) being the most common. |
| Conclusions: | Sorafenib is not effective as frontline therapy in the general unselected non small cell lung cancer population. The window of opportunity design is feasible for estimating the activity of novel compounds. |