Entry Detail
| General information | |
| Database: | DB01006 |
| Objective: | Thisphase II singlearm trial evaluated afatinib, an irreversible inhibitor of the ErbB receptor family as thirdline treatment of Korean patients with advanced non small cell lung cancer (non small cell lung cancer) and tumors with wildtype EGFR. Currently, no standard therapy exists for these patients. |
| Authors: | Ahn MJ, et al |
| Title: | Phase II study of Afatinib as thirdline treatment for patients in Korea with stage IIIB/IV non small cell lung cancer harboring wildtype EGFR. |
| Journal: | Oncologist. |
| Year: | 2014 |
| PMID: | 24868099 |
| Trial Design | |
| Clinical Trial Id: | NCT01003899 |
| Agent: | afatinib |
| Target: | Receptor proteintyrosine kinase erbB2 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: | phase II singlearm trial |
| Key Patients Feature: | Eligible patients had stage IIIB/IV wildtype EGFR lung adenocarcinoma and had failed to benefit from two previous lines of chemotherapy but had not received antiEGFR treatment. |
| Biomarker: | wildtype EGFR |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received oral afatinib at 40 mg per day until disease progression or occurrence of intolerable adverse events (AEs). |
| Primary End Point: | confirmed objective tumor response (OR) rate (confirmed complete response [CR] or partial response [PR]). |
| Secondary End Point: | disease control rate (DCR; OR or stable disease for more than and equal to 6 weeks), progression free survival (PFS), and safety |
| Patients Number: | 42 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 24% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.1 weeks (95% confidence interval: 3.98.0) |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common AEs were rash/acne (37 patients, 88%), follotheyd by diarrhea (26 patients, 62%) and stomatitis (24 patients, 57%)¡ªall known characteristics of EGFR inhibition and consistent with the known safety profile of afatinib. Seventeen patients (40%) had at least one serious AE (SAE); nine had fatal events, but none of the SAEs was considered to be treatment related. There were no events of interstitial lung disease or pneumonitis. |
| Conclusions: | Heavily pretreated patients with wildtype EGFR non small cell lung cancer treated with afatinib monotherapy did not experience an objective response and only 24% had disease stabilization lasting more than 6 weeks. AEs were manageable and consistent with the expected safety profile. |