| General information |
| Database: | DB00823 |
| Objective: | Vascular endothelial growth factor (VEGF)mediated angiogenesis plays an important role in non small cell lung cancer (non small cell lung cancer). Ramucirumab is a human immunoglobulin G1 monoclonal antibody that inhibits VEGF receptor 2. Thisphase 2 study investigated ramucirumab in combination with firstline pemetrexed and platinum chemotherapy in advanced/metastatic non small cell lung cancer |
| Authors: | Doebele RC, et al |
| Title: | Phase 2, randomized, openlabel study of ramucirumab in combination with firstline pemetrexed and platinum chemotherapy in patients with nonsquamous, advanced/metastatic non small cell lung cancer. |
| Journal: | Cancer. |
| Year: | 2015 |
| PMID: | 25377507 |
| Trial Design |
| Clinical Trial Id: | NCT01160744 |
| Agent: | ramucirumab
|
| Target: | Vascular endothelial growth factor receptor 2
|
| 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: | ramucirumab + firstline pemetrexed + platinum chemotherapy |
| Study Type: | Phase II, randomized, openlabel study |
| Key Patients Feature: | Eligible stage IV nonsquamous non small cell lung cancer patients with no prior chemotherapy for metastatic disease |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | pemetrexedplatinum arm verus amucirumabpemetrexedplatinum arm |
| Treatment Info: | patients were randomized 1:1 to pemetrexed and carboplatin (or cisplatin) or ramucirumab (10 mg/kg) plus pemetrexed and carboplatin (or cisplatin) once every 3 weeks. Treatment was given for 4 to 6 cycles, and this was followed by a maintenancephase with pemetrexed or ramucirumab and pemetrexed. |
| Primary End Point: | progression free survival (PFS) with a sample size of sufficient potheyr to detect an increase from 7 to 10.4 months. |
| Secondary End Point: | NA |
| Patients Number: | 140 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 38.0% and 49.3% for the pemetrexedplatinum and ramucirumabpemetrexedplatinum arms, respectively (P = .180). |
| Disease Control Rate: | 70.4% for the pemetrexedplatinum arm and 85.5% for the ramucirumabpemetrexedplatinum arm (P = .032). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.6 months for the pemetrexedplatinum arm and 7.2 months for the ramucirumabpemetrexedplatinum arm (hazard ratio, 0.75; P = .132). |
| Median OS A vs. C: | 10.4 months in PEM + Cb/Cis; 13.9 months in RAM + PEM + Cb/Cis |
| Adverse Event(agent arm): | NA |
| Conclusions: | The primary endpoint of significant prolongation of PFS was not met; hotheyver, ramucirumab showed evidence of clinical activity in combination with pemetrexed and platinum in nonsquamous non small cell lung cancer patients. The addition of ramucirumab to pemetrexed and platinum did not result in new or unexpected safety findings. |