| General information |
| Database: | DB00742 |
| Objective: | This study investigated whether sequential administration of erlotinib and chemotherapy improves clinical outcomes versus chemotherapy alone in unselected, chemotherapyna ve patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Mok TS, et al |
| Title: | Randomized, placebocontrolled, phase II study of sequential erlotinib and chemotherapy as firstline treatment for advanced non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2009 |
| PMID: | 19738125 |
| Trial Design |
| Clinical Trial Id: | NA |
| 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: | Randomized, placebocontrolled, phase II study |
| Key Patients Feature: | Previously untreated patients (n = 154) with stage IIIB or IV non small cell lung cancer and Eastern Cooperative Oncology Group performance status of 0 or 1 |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | erlotinib versus chemotherapy |
| Treatment Info: | pts were randomly assigned to receive erlotinib (150 mg/d) or placebo on days 15 to 28 of a 4week cycle that included gemcitabine (1, 250 mg/m(2) days 1 and 8) and either cisplatin (75 mg/m(2) day 1) or carboplatin (5 x area under the serum concentrationtime curve, day 1). |
| Primary End Point: | nonprogression rate (NPR) at 8 weeks. |
| Secondary End Point: | tumor response rate, NPR at 16 weeks, duration of response, progression free survival (PFS), overall survival (OS), and safety. |
| Patients Number: | 154 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 35.5% for GCerlotinib versus 24.4% for GCplacebo. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | median, 29.4 v 23.4 weeks |
| Median OS A vs. C: | There was no significant difference in OS |
| Adverse Event(agent arm): | NA |
| Conclusions: | Sequential administration of erlotinib following gemcitabineplatinum chemotherapy led to a significant improvement in PFS. This treatment approach warrants further investigation in aphase III study. |