| General information |
| Database: | DB01004 |
| Objective: | Ramucirumab is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR2. they aimed to assess efficacy and safety of treatment with docetaxel plus ramucirumab or placebo as secondline treatment for patients with stage IV non small cell lung cancer (non small cell lung cancer) after platinumbased therapy |
| Authors: | Garon EB, et al |
| Title: | Ramucirumab plus docetaxel versus placebo plus docetaxel for secondline treatment of stage IV non small cell lung cancer after disease progression on platinumbased therapy (REVEL): a multicentre, doubleblind, randomisedphase 3 trial. |
| Journal: | Lancet. |
| Year: | 2014 |
| PMID: | 24933332 |
| Trial Design |
| Clinical Trial Id: | NCT01168973 |
| 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 + docetaxel |
| Study Type: | a multicentre, doubleblind, randomisedphase III trial. |
| Key Patients Feature: | patients with squamous or nonsquamous non small cell lung cancer who had progressed during or after a firstline platinumbased chemotherapy regimen. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Ramucirumab plus docetaxel versus placebo plus docetaxel |
| Treatment Info: | patients were randomly allocated (1:1) with a centralised, interactive voiceresponse system (stratified by sex, region, performance status, and previous maintenance therapy [yes vs no]) to receive docetaxel 75 mg/m(2) and either ramucirumab (10 mg/kg) or placebo on day 1 of a 21 day cycle until disease progression, unacceptable toxicity, withdrawal, or death. |
| Primary End Point: | overall survival; adverse events according to treatment received. |
| Secondary End Point: | NA |
| Patients Number: | 1825 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 23% of patients in the ramucirumab group had an investigatorassessed ORR compared with 14% controls |
| Disease Control Rate: | 64% patients in the ramucirumab group vs 53% controls; 1.60, 1.28-2.01; p<0.0001 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.5 months (IQR 2.38.3) for the ramucirumab group compared with 3.0 months (1.46.9) for the control group (0.76, 0.680.86; p<0.0001). |
| Median OS A vs. C: | 10.5 months (IQR 5.121.2) for ramucirumab plus docetaxel and 9.1 months (4.218.0) for placebo plus docetaxel (hazard ratio 0.86, 95% CI 0.750.98; p=0.023). |
| Adverse Event(agent arm): | The most common adverse events leading to dose adjustments for ramucirumab compared with placebo were neutropenia (77 [12%] patients in the ramucirumab group vs 55 [9%] controls), fatigue (54 [9%] patients vs 34 [6%] controls), and febrile neutropenia (44 [7%] patients vs 28 [5%] controls). |
| Conclusions: | Ramucirumab plus docetaxel improves survival as secondline treatment of patients with stage IV non small cell lung cancer. |