| General information |
| Database: | DB00169 |
| Objective: | Patients with advanced squamouscell non small cell lung cancer (non small cell lung cancer) who have disease progression during or after firstline chemotherapy have limited treatment options. This randomized, openlabel, international, phase 3 study evaluated the efficacy and safety of nivolumab, a fully human IgG4 programmed death 1 (PD1) immunecheckpointinhibitor antibody, as compared with docetaxel in this patient population. |
| Authors: | Brahmer J, et al |
| Title: | Nivolumab versus Docetaxel in Advanced SquamousCell non small cell Lung Cancer. |
| Journal: | N Engl J Med. |
| Year: | 2015 |
| PMID: | 26028407 |
| Trial Design |
| Clinical Trial Id: | NCT01642004 |
| Agent: | nivolumab
|
| Target: | PD1
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced squamouscell non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a randomized, openlabel, international, phase III study |
| Key Patients Feature: | Patients with advanced squamouscell non small cell lung cancer (non small cell lung cancer) who have disease progression during or after firstline chemotherapy |
| Biomarker: | The expression of the PD1 ligand (PDL1) |
| Biomark Analysis: | The expression of the PD1 ligand (PDL1) was neither prognostic nor predictive of benefit. |
| Control Group Info: | Docetaxel |
| Treatment Info: | randomly assigned 272 patients to receive nivolumab, at a dose of 3 mg per kilogram of body weight every 2 weeks, or docetaxel, at a dose of 75 mg per square meter of bodysurface area every 3 weeks. |
| Primary End Point: | overall survival. |
| Secondary End Point: | NA |
| Patients Number: | 272 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The response rate was 20% with nivolumab versus 9% with docetaxel (P=0.008). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median progression free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel (hazard ratio for death or disease progression, 0.62; 95% CI, 0.47 to 0.81; P<0.001). |
| Median OS A vs. C: | The median overall survival was 9.2 months (95% confidence interval [CI], 7.3 to 13.3) with nivolumab versus 6.0 months (95% CI, 5.1 to 7.3) with docetaxel. The risk of death was 41% lotheyr with nivolumab than with docetaxel (hazard ratio, 0.59; 95% CI, 0.44 to 0.79; P<0.001). At 1 year, the overall survival rate was 42% (95% CI, 34 to 50) with nivolumab versus 24% (95% CI, 17 to 31) with docetaxel. |
| Adverse Event(agent arm): | Treatmentrelated adverse events of grade 3 or 4 were reported in 7% of the patients in the nivolumab group as compared with 55% of those in the docetaxel group. |
| Conclusions: | Among patients with advanced, previously treated squamouscell non small cell lung cancer, overall survival, response rate, and progression free survival were significantly better with nivolumab than with docetaxel, regardless of PDL1 expression level. |