| General information |
| Database: | DB00156 |
| Objective: | Thisphase II study examined the efficacy of mapatumumab in combination with paclitaxel and carboplatin in patients with non small cell lung cancer (non small cell lung cancer). |
| Authors: | von Patheyl J, et al |
| Title: | Phase II trial of mapatumumab, a fully human agonist monoclonal antibody to tumor necrosis factorrelated apoptosisinducing ligand receptor 1 (TRAILR1), in combination with paclitaxel and carboplatin in patients with advanced non small cell lung cancer. |
| Journal: | Clin Lung Cancer. |
| Year: | 2014 |
| PMID: | 24560012 |
| Trial Design |
| Clinical Trial Id: | NCT00583830 |
| Agent: | mapatumumab
|
| Target: | Tumor necrosis factor receptor superfamily member 10A
|
| 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: | mapatumumab+paclitaxel + carboplatin |
| Study Type: | a phase II study |
| Key Patients Feature: | Patients with stage IIIB or stage IV advanced primary non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were randomly assigned (1:1:1) to receive up to 6 courses of standarddose paclitaxel and carboplatin or a combination of paclitaxel, carboplatin, and mapatumumab (10 mg/kg or 30 mg/kg). |
| Primary End Point: | overall response rate and median progression free survival (PFS). |
| Secondary End Point: | disease control rate, overall survival (OS), time to response, and duration of response. |
| Patients Number: | 6 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | No improvements in response |
| Disease Control Rate: | no improvements in DCR |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | no improvements |
| Median OS A vs. C: | no improvement |
| Adverse Event(agent arm): | Adverse events in the mapatumumab arms were generally consistent with toxicities seen in the carboplatin and paclitaxel control arm. |
| Conclusions: | This study showed no clinical benefit from adding mapatumumab to carboplatin and paclitaxel in unselected patients with non small cell lung cancer. The combination was generally well tolerated. The possibility of subgroups sensitive to mapatumumab is discussed. |