Entry Detail
| General information | |
| Database: | DB00085 |
| Objective: | prospectively assessed the efficacy and safety of cisplatin plus gemcitabine with either Sorafenib or placebo as firstline therapy for non small cell lung cancer. |
| Authors: | Wang Y, et al |
| Title: | Randomize trial of cisplatin plus gemcitabine with either sorafenib or placebo as firstline therapy for non small cell lung cancer. |
| Journal: | Zhongguo Fei Ai Za Zhi. |
| Year: | 2011 |
| PMID: | 21426666 |
| Trial Design | |
| Clinical Trial Id: | NA |
| 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: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cisplatin+gemcitabine+sorafenib |
| Study Type: | a phase III Randomize trial of cisplatin+gemcitabine with either sorafenib or placebo as firstline therapy for non small cell lung cancer |
| Key Patients Feature: | patients, which were confirmed advanced non small cell lung cancer histologically or cytologically |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | chemotherapy only |
| Treatment Info: | patients were randomly assigned to receive up to six cycles of cisplatin plus gemcitabine with sorafenib or placebo. The maintenance of sorafenib or placebo after chemotherapy will continued in patients with response or stable disease until disease progression or unacceptable adverse events. |
| Primary End Point: | response rate, PFS, OS |
| Secondary End Point: | NA |
| Patients Number: | 30 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | (Overall response) rate was 55.6% and 41.7% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5 vs 4, P=0.75(sorafenib+chemotherapy vs chemotherapy alone) |
| Median OS A vs. C: | 55.6% and 41.7%(P=0.905). |
| Adverse Event(agent arm): | Adverse events were tolerable, though the risk of hypertension and diarrhea was increase in experimental arm |
| Conclusions: | No additional benefit of response rate, PFS or OS they were observed from adding targeted agentsorafenib to regular cisplatin plus gemcitabine chemotherapy. Selecting aproper patients is needed in further study. |