Entry Detail
| General information | |
| Database: | DB00855 |
| Objective: | the phase 3 MONET1 study evaluated motesanib (a smallmolecule inhibitor of vascular endothelial growth factor receptors) plus carboplatin/paclitaxel versus placebo plus carboplatin/paclitaxel as firstline therapy for advanced non small cell lung cancer (non small cell lung cancer). Treatment and enrollment of patients with squamous histology were permanently discontinued following higher early mortality and gross hemoptysis in those with squamous non small cell lung cancer who received motesanib. Enrollment of patients with nonsquamous histology was temporarily halted, but resumed following a protocol amendment (Scagliotti et al. J Clin Oncol. 2012;30:28292836). Herein, they report data from the squamous cohort |
| Authors: | Novello S, et al |
| Title: | Motesanib plus carboplatin/paclitaxel in patients with advanced squamous non small cell lung cancer: results from the randomized controlled MONET1 study. |
| Journal: | J Thorac Oncol. |
| Year: | 2014 |
| PMID: | 25157768 |
| Trial Design | |
| Clinical Trial Id: | NCT00460317 |
| Agent: | motesanib |
| Target: | Mast/stem cell growth factor receptor Plateletderived growth factor receptor Vascular endothelial growth factor receptor 2 |
| 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: | Motesanib + carboplatin/paclitaxel |
| Study Type: | randomized controlled MONETI study |
| Key Patients Feature: | Patients with stage IIIB/IV or recurrent squamous non small cell lung cancer (without prior systemic therapy for advanced disease) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | motesanibversus placebo |
| Treatment Info: | pts received up to six 3week cycles of chemotherapy (carboplatin, area under the curve 6 mg/mL min/paclitaxel, 200 mg/m) and were randomized 1:1 to receive motesanib 125 mg (Arm A) or placebo (Arm B) once daily. |
| Primary End Point: | overall survival |
| Secondary End Point: | NA |
| Patients Number: | 360 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | in Arm A was 38% compared with 35% in Arm B |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.9 months (95% CI, 4.2-5.6 months) and 5.1 months (95% CI, 4.4-5.6 months) in Arms A and B, respectively (HR, 0.85; 95% CI, 0.65-1.11; p = 0.2294) |
| Median OS A vs. C: | in Arm A was 11.1 months (95% confidence interval [CI], 9.0-12.8 months) compared with 10.7 months (95% CI, 9.4-12.1 months) in Arm B (HR, 0.89; 95% CI, 0.71-1.12; p = 0.3306) |
| Adverse Event(agent arm): | NA |
| Conclusions: | Motesanib plus carboplatinpaclitaxel had unacceptable toxicity compared with carboplatinpaclitaxel alone in patients with advanced squamous non small cell lung cancer. |