| General information |
| Database: | DB00173 |
| Objective: | Bavituximab is a phosphatidylserine (PS)targeting monoclonal antibody with immunemodulating and tumorspecific vascular targeting properties. Preclinical studies have shown activity against numerous solid tumors and at least an additive effect in combination with chemotherapy. This study evaluated bavituximab in combination with paclitaxel and carboplatin in patients with previously untreated, locally advanced or metastatic non small cell lung cancer. |
| Authors: | Digumarti R, et al |
| Title: | Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non small cell lung cancer. |
| Journal: | Lung Cancer. |
| Year: | 2014 |
| PMID: | 25236982 |
| Trial Design |
| Clinical Trial Id: | NCT00687817 |
| Agent: | bavituximab
|
| Target: | membrane phospholipid phosphatidylserine (PS)
|
| 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: | bavituximab+paclitaxel+ carboplatin |
| Study Type: | a phase II, openlabel study |
| Key Patients Feature: | patients with stage IIIB/IV non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | a Simon twostage design. patients were treated with up to six cycles of carboplatin area under the concentrationtime curve (AUC) 5 plus paclitaxel 175 mg/m2 every 21 days with weekly bavituximab 3 mg/kg followed by bavituximab monotherapy until progression or unacceptable toxicity. |
| Primary End Point: | overall response rate |
| Secondary End Point: | PFS, OS, Aes |
| Patients Number: | 49 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | (ORR) was 40.8% (complete response [CR] 2.0%, partial response [PR] was 38.8%). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.0 months |
| Median OS A vs. C: | 12.4 months |
| Adverse Event(agent arm): | Treatmentrelated adverse events (AEs) occurred in 40.8% of patients. The most common treatmentrelated AEs were anemia (10.2%), asthenia, vomiting, paresthesia, anorexia, and fatigue (6.1% each). One patient with a central, cavitating squamous tumor developed fatal hemoptysis and aspiration. |
| Conclusions: | Bavituximab in combination with paclitaxelcarboplatin as firstline therapy demonstrated a tolerable safety profile and potential efficacy in this singlearmphase II trial in patients with advanced local or metastatic non small cell lung cancer. Randomized trials with this regimen are in progress. |