Entry Detail
| General information | |
| Database: | DB00857 |
| Objective: | The efficacy and safety of axitinib, a potent and selective secondgeneration inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 in combination with pemetrexed and cisplatin was evaluated in patients with advanced nonsquamous non small cell lung cancer (non small cell lung cancer). |
| Authors: | Belani CP, et al |
| Title: | Randomizedphase II study of pemetrexed/cisplatin with or without axitinib for nonsquamous non small cell lung cancer. |
| Journal: | BMC Cancer. |
| Year: | 2014 |
| PMID: | 24766732 |
| Trial Design | |
| Clinical Trial Id: | NCT00768755 |
| Agent: | axitinib |
| Target: | Macrophage colonystimulating factor 1 Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | nonsquamous non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | pemetrexed/cisplatin with axitinib |
| Study Type: | Randomizedphase II study |
| Key Patients Feature: | Patients aged 18 years and older (more than and equal to 20 years in Japan) with histologically or cytologically confirmed stage IIIB with malignant pleural or pericardial effusion, stage IV, or recurrent nonsquamous non small cell lung cancer were eligible. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | pemetrexed/cisplatin with axitinib versus pemetrexed/cisplatin |
| Treatment Info: | patients were randomly assigned to receive axitinib at a starting dose of 5mg twice daily continuously plus pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) on day 1 of up to six 21day cycles (arm I); axitinib on days 2 through 19 of each cycle plus pemetrexed/cisplatin (arm II); or pemetrexed/cisplatin alone (arm III). |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | NA |
| Patients Number: | 170 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 45.5% (arm I) and 39.7% (arm II) compared with 26.3% for pemetrexed/cisplatin alone (arm III). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 8.0, 7.9, and 7.1 months in arms I, II, and III, respectively (hazard ratio: arms I vs. III, 0.89 [P = 0.36] and arms II vs. III, 1.02 [P = 0.54]) |
| Median OS A vs. C: | 17.0 months (arm I), 14.7 months (arm II), and 15.9 months (arm III). |
| Adverse Event(agent arm): | Median (95% CI) duration of tumor response among responders was 7.8 (5.6-11.4), 6.7 (5.0-7.8), and 7.1 (4.2-24.7) months in arms I (n = 25), II (n = 23), and III (n = 15), respectively. |
| Conclusions: | Axitinib in combination with pemetrexedcisplatin was generally well tolerated. Axitinib combinations resulted in nonsignificant differences in PFS and numerically higher ORR compared with chemotherapy alone in advanced non small cell lung cancer. |