Entry Detail
| General information | |
| Database: | DB00083 |
| Objective: | ThisphaseII study in heavily pretreated non small cell lung cancer (non small cell lung cancer) patients (more than and equal to 2 prior therapies) used a randomized discontinuation design |
| Authors: | Heather A. Wakelee, et al |
| Title: | A doubleblind randomized discontinuationphaseII study of sorafenib (BAY 439006) in previously treated non small cell lung cancer patients: eastern cooperative oncology group study E2501. |
| Journal: | J Thorac Oncol |
| Year: | 2012 |
| PMID: | 22982658 |
| 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: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A randomizedphase II discontinuation design study run through the Eastern Cooperative Oncology Group (ECOG) at member institutions |
| Key Patients Feature: | advanced stage non small cell lung cancer with disease progression after having received at least two prior chemotherapy regimens (prior epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKI) therapy was not counted as chemotherapy). Patients must have completed all therapy at least three weeks prior to study entry |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | placebo |
| Treatment Info: | Patients received 400 mg of sorafenib orally twice daily for two cycles (2 months) (step 1). Responding patients on step 1 continued on sorafenib; progressing patients theynt off study, and patients with stable disease were randomized to placebo or sorafenib (step 2), with crossover from placebo allowed upon progression. |
| Primary End Point: | the proportion of patients having stable or responding disease 2 months after randomization. |
| Secondary End Point: | NA |
| Patients Number: | 299 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | The 2month disease control rates after randomization were 54% and 23%(A vs placebo, p = 0.005) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The HR for progression on step 2 was 0.51 (95% [confidence interval] CI 0.30, 0.87, p = 0.014) |
| Median OS A vs. C: | 13.7 vs 9.0 from time of randomization in step 2, A vs placebo), HR 0.67 (95% CI 0.401.11), p = 0.117 |
| Adverse Event(agent arm): | Toxicities were manageable and as expected |
| Conclusions: | The results of this randomized discontinuation trial suggest that sorafenib has single agent activity in a heavily pretreated, enriched patient population with advanced non small cell lung cancer. These results support further investigation with sorafenib as a single agent in larger, randomized studies in non small cell lung cancer. |