Entry Detail
| General information | |
| Database: | DB00084 |
| Objective: | Patients with advanced non small cell lung cancer were treated with erlotinib with or without sorafenib in this multicenterphase II trial. |
| Authors: | Spigel DR, et al |
| Title: | Randomized, doubleblind, placebocontrolled, phase II trial of sorafenib and erlotinib or erlotinib alone in previously treated advanced non small cell lung cancer. |
| Journal: | J Clin Oncol |
| Year: | 2011 |
| PMID: | 21576636 |
| Trial Design | |
| Clinical Trial Id: | NCT00600015. |
| 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 NSCL |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | sorafenib+erlotinib |
| Study Type: | a phase II, randomized, doubleblind, placebocontrolled trial of sorafenib plus erlotinib or placebo plus erlotinib after the failure of firstline or secondline chemotherapy for non small cell lung cancer |
| Key Patients Feature: | Patients age 18 years or older with documented pathologic evidence of non small cell lung cancer and have received one to two prior chemotherapy regimens for advanced non small cell lung cancer and had measurable disease per RECIST |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | placebo plus erlotinib |
| Treatment Info: | patients were randomly assigned 2:1 to sorafenib (400 mg orally twice a day) plus erlotinib (150 mg orally daily) or placebo plus erlotinib and stratified by squamous/nonsquamous histology and prior bevacizumab. |
| Primary End Point: | Treatment efficacy, measured by progression free survival (PFS) and overall response rate (ORR), was compared. |
| Secondary End Point: | NA |
| Patients Number: | 168 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | sorafenib/erlotinib and placebo/erlotinib were 8% and 11%, respectively (P = .56); |
| Disease Control Rate: | 54% vs 38% (P = .056) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.38 vs 1.94, 0.86; 95% CI, 0.60 to 1.22; P = .196 |
| Median OS A vs. C: | 8 vs 4.5, P =0.019;An OS advantage for sorafenib/erlotinib was suggested among 43 patients with fluorescent in situ hybridization (FISH) EGFRnegative tumors (P = .064). |
| Adverse Event(agent arm): | Both regimens were tolerable, with modest toxicity increase with sorafenib. |
| Conclusions: | Although there was little difference in ORR or PFS, subset analyses in EGFR WT and EGFR FISHnegative patients suggest a benefit for the combination of erlotinibsorafenib compared with singleagent erlotinib with respect to PFS and OS. |