| General information |
| Database: | DB00866 |
| Objective: | Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors have proven efficacy in advanced non small cell lung cancer (non small cell lung cancer). they hypothesized that erlotinib would be efficacious in the adjuvant setting. |
| Authors: | Kelly K, et al |
| Title: | Adjuvant Erlotinib Versus Placebo in Patients With Stage IBIIIA non small cell Lung Cancer (RADIANT): A Randomized, DoubleBlind, phase III Trial. |
| Journal: | J Clin Oncol. |
| Year: | 2015 |
| PMID: | 26324372 |
| Trial Design |
| Clinical Trial Id: | NCT00373425 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | Stage IBIIIA non small cell Lung Cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | A Randomized, DoubleBlind, phase III Trial |
| Key Patients Feature: | patients with completely resected IB to IIIA non small cell lung cancer whose tumors expressed EGFR protein by immunohistochemistry or EGFR amplification by fluorescence in situ hybridization |
| Biomarker: | tumors expressed EGFR protein by immunohistochemistry or EGFR amplification by fluorescence in situ hybridization |
| Biomark Analysis: | Among the 161 patients (16.5%) in the EGFRmpositive subgroup, DFS favored erlotinib (median, 46.4 v 28.5 months; hazard ratio, 0.61; 95% CI, 0.38 to 0.98; P = .039), but this was not statistically significant because of the hierarchical testing procedure. |
| Control Group Info: | Erlotinib Versus Placebo |
| Treatment Info: | Patients were assigned 2:1 to erlotinib 150 mg once per day or placebo for 2 years. Stratification factors were stage, histology, previous adjuvant chemotherapy, smoking status, EGFR amplification status, and country |
| Primary End Point: | diseasefree survival (DFS); |
| Secondary End Point: | overall survival (OS) and DFS and OS in patients whose tumors had EGFRactivating mutations (EGFRmpositive) |
| Patients Number: | 973 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 50.5 months for erlotinib and 48.2 months for placebo; hazard ratio, 0.90; 95% CI, 0.74 to 1.10; P = .324 |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Adjuvant erlotinib did not prolong DFS in patients with EGFRexpressing non small cell lung cancer or in the EGFRmpositive subgroup. Further evaluation of erlotinib is warranted in the EGFRmpositive subgroup. |