| General information |
| Database: | DB00776 |
| Objective: | Tivantinib, a MET receptor tyrosine kinase inhibitor, demonstrated increased anticancer activity in preclinical and early clinical studies when combined with erlotinib. Our study aimed to confirm efficacy and safety of the combination in previously treated patients with non small cell lung cancer (non small cell lung cancer). |
| Authors: | Scagliotti G, et al |
| Title: | Phase III Multinational, Randomized, DoubleBlind, PlaceboControlled Study of Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone in Previously Treated Patients With Locally Advanced or Metastatic Nonsquamous non small cell Lung Cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2015 |
| PMID: | 26169611 |
| Trial Design |
| Clinical Trial Id: | NCT01244191 |
| Agent: | Tivantinib (ARQ 197) and Erlotinib
|
| Target: | NA
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | Tivantinib (ARQ 197) + Erlotinib |
| Study Type: | Phase III Multinational, Randomized, DoubleBlind, PlaceboControlled Study |
| Key Patients Feature: | Patients with advanced nonsquamous non small cell lung cancer previously treated with one to two systemic regimens, including a platinum doublet |
| Biomarker: | EGFR and KRAS mutations, MET expression, and MET gene amplification |
| Biomark Analysis: | Exploratory subgroup analyses suggested OS improvement in patients with high MET expression (HR, 0.70; 95% CI, 0.49 to 1.01). |
| Control Group Info: | Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone |
| Treatment Info: | patients were randomly assigned at a 1:1 ratio to receive erlotinib 150 mg daily plus oral tivantinib 360 mg twice daily (E + T) or erlotinib plus placebo (E + P) until disease progression. |
| Primary End Point: | overall survival (OS) |
| Secondary End Point: | progression free survival (PFS), OS in molecular subgroups, and safety. |
| Patients Number: | 1048 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | with E + T versus E + P: median PFS, 3.6 v 1.9 months; HR, 0.74; 95% CI, 0.62 to 0.89; P < .001 |
| Median OS A vs. C: | with E + T versus E + P (median OS, 8.5 v 7.8 months, respectively; hazard ratio [HR], 0.98; 95% CI, 0.84 to 1.15; P = .81) |
| Adverse Event(agent arm): | NA |
| Conclusions: | E + T was well tolerated and increased PFS but did not improve OS in the overall nonsquamous non small cell lung cancer population. |