| General information |
| Database: | DB00815 |
| Objective: | R1507 is a selective, fully human, recombinant monoclonal antibody (immunoglobulin G1 subclass) against insulinlike growth factor1 receptor (IGF1R). The strong preclinical evidence supporting coinhibition of IGF1R and epidermal growth factor receptor (EGFR) as anticancer therapy prompted this study. |
| Authors: | Ramalingam SS, et al |
| Title: | Randomizedphase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulinlike growth factor1 receptor, for advancedstage non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2011 |
| PMID: | 22025157 |
| Trial Design |
| Clinical Trial Id: | NCT00760929 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advancedstage non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | erlotinib+R1507 |
| Study Type: | Randomizedphase II study |
| Key Patients Feature: | Patients with advancedstage non small cell lung cancer (non small cell lung cancer) with progression following one or two prior regimens, Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, and measurable disease were eligible. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | erlotinib in combination with placebo verus erlotinib in combination with R1507 |
| Treatment Info: | patients were randomly assigned to receive erlotinib (150 mg orally once a day) in combination with either placebo, R1507 9 mg/kg weekly, or R1507 16 mg/kg intravenously once every 3 weeks. Treatment cycles were repeated every 3 weeks. |
| Primary End Point: | comparison of the 12week progression free survival (PFS) rate. |
| Secondary End Point: | NA |
| Patients Number: | 172 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 8.8%, 8.8%, and 7% for the three arms. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The 12week PFS rates were 39%, 37%, and 44% |
| Median OS A vs. C: | the median overall survival was 8.1, 8.1, and 12.1 months for the three groups, respectively |
| Adverse Event(agent arm): | The overall incidence of adverse events was higher with the combination regimen |
| Conclusions: | The combination of R1507 with erlotinib did not provide PFS or survival advantage over erlotinib alone in an unselected group of patients with advanced non small cell lung cancer. Predictive biomarkers are essential for further development of combined inhibition of IGF1R and EGFR. |