| General information |
| Database: | DB00826 |
| Objective: | The objective of this study was to determine whether the addition of ramucirumab to firstline paclitaxelcarboplatin chemotherapy in patients with advanced non small cell lung cancer (non small cell lung cancer) resulted in a 6month progression free survival (PFS) rate that compares favorably with the historic rate for bevacizumab combined with paclitaxelcarboplatin in this patient population |
| Authors: | Camidge DR, et al |
| Title: | a phase II, openlabel study of ramucirumab in combination with paclitaxel and carboplatin as firstline therapy in patients with stage IIIB/IV non small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2014 |
| PMID: | 25170639 |
| Trial Design |
| Clinical Trial Id: | NCT00735696 |
| Agent: | ramucirumab
|
| Target: | 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: | ramucirumab + paclitaxel + carboplatin as |
| Study Type: | a phase II, singlearm, openlabel, multicenter study |
| Key Patients Feature: | patients with stage IIIB/IV non small cell lung cancer. |
| Biomarker: | SNP on FGFR2 gene |
| Biomark Analysis: | Singlenucleotide polymorphism (SNP) rs2981582 on the FGFR2gene had significant associations with improved overall survival, PFS, and best overall response (p values without multiplicity adjustment were 0.0059, 0.0429, and 0.0392, respectively). |
| Control Group Info: | ramucirumab in combination with paclitaxel and carboplatin verus ramucirumab alone |
| Treatment Info: | pts received ramucirumab (10 mg/kg intravenous [IV]) followed by paclitaxel (200 mg/m IV) and carboplatin area under the curve = 6 on day 1 every 21 days as firstline therapy. Therapy continued for up to six cycles. Patients not experiencing withdrawal criteria may have continued ramucirumab monotherapy every 3 weeks. |
| Primary End Point: | PFS at 6 months, with 80% power to detect a 6month PFS rate of at least 55%. |
| Secondary End Point: | NA |
| Patients Number: | 40 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 55.00% |
| Disease Control Rate: | 90.0% (95% CI: 76.3-97.2%) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The 6month PFS rate was 59.0%; median: 7.85 months (95% CI: 5.49-9.86 months) |
| Median OS A vs. C: | 16.85 months (95% CI: 14.82-28.58 months) |
| Adverse Event(agent arm): | The most common treatmentrelated TEAEs (of all grades) were fatigue (21 patients, 52.5%), peripheral neuropathy (13 patients, 32.5%), nausea (11 patients, 27.5%), and epistaxis and myalgia (9 patients each, 22.5%). Ten patients (25.0%) experienced a grade 3 treatmentrelated TEAE and five patients (12.5%) experienced a grade 4 treatmentrelated TEAE. Neutropenia (four patients, 10.0%), thrombocytopenia and fatigue (three patients each, 7.5%), and peripheral neuropathy (two patients, 5.0%) were the most frequently reported grade 3 treatmentrelated TEAEs |
| Conclusions: | Ramucirumab in combination with paclitaxelcarboplatin resulted in a 6month PFS rate and safety profile that compared favorably with the historical control. In addition, no deaths they were associated with this treatment. Furthermore, they describe an association of SNP on FGFR2 gene with survival and response. These findings warrant further clinical investigation in patients with non small cell lung cancer. |