Entry Detail
| General information | |
| Database: | DB00088 |
| Objective: | to evaluate the antitumor response and tolerability of sorafenib in patients with relapsed or refractory, advanced non small cell lung cancer, most of whom had received prior platinumbased chemotherapy. |
| Authors: | Blumenschein GR Jr, et al. |
| Title: | Phase II, multicenter, uncontrolled trial of singleagent sorafenib in patients with relapsed or refractory, advanced non small cell lung cancer. |
| Journal: | J Clin Oncol |
| Year: | 2009 |
| PMID: | 19652055 |
| Trial Design | |
| Clinical Trial Id: | NCT00101413. |
| 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 phase II, singlearm, multicenter study |
| Key Patients Feature: | Patients with relapsed or refractory advanced non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received sorafenib 400 mg orally twice daily until tumor progression or an unacceptable drugrelated toxicity occurred. |
| Primary End Point: | response rate |
| Secondary End Point: | NA |
| Patients Number: | 52 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | No CR or PR were observed. SD was achieved in 30 (59%) of the 51 patients who were evaluable for efficacy. Four patients with SD developed tumor cavitation |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.7, patients with SD had a median PFS of 5.5 months. |
| Median OS A vs. C: | 6.7 |
| Adverse Event(agent arm): | Major grades 3 to 4, treatmentrelated toxicities included handfoot skin reaction (10%), hypertension (4%), fatigue (2%), and diarrhea (2%). Nine patients died within a 30day period after discontinuing sorafenib, and one patient experienced pulmonary hemorrhage that was considered drug related. |
| Conclusions: | Continuous treatment with sorafenib 400 mg twice daily was associated with disease stabilization in patients with advanced non small cell lung cancer. The broad activity of sorafenib and its acceptable toxicity profile suggest that additional investigation of sorafenib as therapy for patients with non small cell lung cancer is warranted. |