Entry Detail
| General information | |
| Database: | DB00061 |
| Objective: | New molecular targeted agents are needed for patients with non small cell lung cancer (non small cell lung cancer) who progress while receiving erlotinib, gefitinib, or both. Afatinib, an oral irreversible ErbB family blocker, has preclinical activity in epidermal growth factor receptor (EGFR [ErbB1]) mutant models with EGFRactivating mutations, including T790M. |
| Authors: | Katakami N, et al |
| Title: | LUXLung 4: a phase II trial of afatinib in patients with advanced non small cell lung cancer who progressed during prior treatment with erlotinib, gefitinib, or both. |
| Journal: | J Clin Oncol. |
| Year: | 2013 |
| PMID: | 23816963 |
| Trial Design | |
| Clinical Trial Id: | NCT00711594 |
| Agent: | afatinib |
| Target: | Receptor proteintyrosine kinase erbB2 Epidermal growth factor receptor |
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II |
| Key Patients Feature: | Japanese singlearm |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received afatinib 50 mg per day. |
| Primary End Point: | objective response rate (complete response or partial response) by independent review. |
| Secondary End Point: | progression free survival (PFS), overall survival (OS), and safety. |
| Patients Number: | 62 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Of 61 evaluable patients, five (8.2%; 95% CI, 2.7%to 18.1%) had a confirmed objective response rate (partial response). |
| Disease Control Rate: | 65.6% 95%CI(52.3 to 77.3) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.4 |
| Median OS A vs. C: | 19 |
| Adverse Event(agent arm): | diarrhea (100%) and rash/acne (91.9%). |
| Conclusions: | Afatinib demonstrated modest but noteworthy efficacy in patients with non small cell lung cancer who had received third or fourthline treatment and who progressed while receiving erlotinib andor gefitinib, including those with acquired resistance to erlotinib, gefitinib, or both. |