| General information |
| Database: | DB00765 |
| Objective: | This study is to analyze the data of Chinese subpopulation in the Tarceva Lung Cancer Survival Treatment Study (TRUSTChina) which was a globalphase IV study designed to provide erlotinib to previously treated patients with Stage IIIB/IV non small cell lung cancer. |
| Authors: | Huang Y, et al |
| Title: | Efficacy of erlotinib in previously treated patients with advanced non small cell lung cancer: analysis of the Chinese subpopulation in the TRUST study. |
| Journal: | Jpn J Clin Oncol. |
| Year: | 2015 |
| PMID: | 25855621 |
| Trial Design |
| Clinical Trial Id: | NCT00949910 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | analysis of the Chinese subpopulation in the TRUST study. |
| Key Patients Feature: | Patients with pathologically confirmed, unresectable Stage IIIB/IV non small cell lung cancer who were previously failed on or unsuitable for chemotherapy or radiotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were given erlotinib (150 mg/day, oral) until disease progression, intolerable toxicity or death. |
| Primary End Point: | Efficacy and toxicity of the agent |
| Secondary End Point: | NA |
| Patients Number: | 519 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 24.70% |
| Disease Control Rate: | 75.30% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median progression free survival was 6.4 months in the general Chinese population in the TRUST, and 10.2 months in nonsmokers with adenocarcinoma (n = 254). |
| Median OS A vs. C: | Median overall survival was 15.4 months in the general Chinese population in the TRUST, and 18.9 months in nonsmokers with adenocarcinoma (n = 254). |
| Adverse Event(agent arm): | clinically significant adverse events of rash and interstitial lung disease in the Asian subgroup were observed in four patients (<1%) and one patient (<0.1%), respectively. |
| Conclusions: | they confirmed the efficacy and safety of erlotinib in Chinese patients. Nonsmoking patients with adenocarcinoma histology had the best clinical benefits. (NCT00949910). |