Entry Detail
| General information | |
| Database: | DB00057 |
| Objective: | The LUXLung 3 study investigated the efficacy of chemotherapy compared with afatinib, a selective, orally bioavailable ErbB family blocker that irreversibly blocks signaling from epidermal growth factor receptor (EGFR/ErbB1), human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2/ErbB2), and ErbB4 and has widespectrum preclinical activity against EGFR mutations. a phase II study of afatinib in EGFR mutationpositive lung adenocarcinoma demonstrated high response rates and progression free survival (PFS). |
| Authors: | Sequist LV, et al |
| Title: | Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. |
| Journal: | J Clin Oncol |
| Year: | 2013 |
| PMID: | 23816960 |
| Trial Design | |
| Clinical Trial Id: | NCT00949650 |
| Agent: | afatinib |
| Target: | Receptor proteintyrosine kinase erbB2 Epidermal growth factor receptor |
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma and EGFR mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase III LUXLung III study |
| Key Patients Feature: | 133 centers in 25 countries in Asia, Europe, North America, South America, and Australia |
| Biomarker: | EGFR mutations |
| Biomark Analysis: | Median PFS among those with exon 19 deletions and L858R EGFR mutations (n = 308) was 13.6 months for afatinib and 6.9 months for chemotherapy (HR, 0.47; 95% CI, 0.34 to 0.65; P = .001). |
| Control Group Info: | cisplatin+pemetrexed |
| Treatment Info: | Mutationpositive patients were stratified by mutation type (exon 19 deletion, L858R, or other) and race (Asian or nonAsian) before twotoone random assignment to 40 mg afatinib per day or up to six cycles of cisplatin plus pemetrexed chemotherapy at standard doses every 21 days. |
| Primary End Point: | PFS by independent review. |
| Secondary End Point: | tumor response, overall survival, adverse events, and patientreported outcomes (PROs). |
| Patients Number: | 345 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.1 vs 6.9;0.58; 95% CI, 0.430.78; P = .001 |
| Median OS A vs. C: | 16.6 vs 14.8;(HR, 1.12; 95% CI, 0.73 to 1.73; P = .60 |
| Adverse Event(agent arm): | diarrhea, rash/acne, and stomatitis |
| Conclusions: | Afatinib is associated with prolongation of PFS when compared with standard doublet chemotherapy in patients with advanced lung adenocarcinoma and EGFR mutations. |