Entry Detail
| General information | |
| Database: | DB00270 |
| Objective: | Afatinib, an irreversible ErbB family blocker, was recently approved for the firstline treatment of EGFR mutationpositive metastatic non small cell lung cancer. Afatinib has also shown clinical activity similar to cetuximab in a phase II proofofconcept HNSCC trial. Based on these observations, the phase III, LUXHead & Neck 1 study is evaluating afatinib versus methotrexate in R/M HNSCC patients following progression on platinumbased chemotherapy in the R/M setting. |
| Authors: | Machiels JP, et al |
| Title: | Rationale and design of LUXHead & Neck 1: a randomised, phase III trial of afatinib versus methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who progressed after platinumbased therapy. |
| Journal: | BMC Cancer. |
| Year: | 2014 |
| PMID: | 24973959 |
| Trial Design | |
| Clinical Trial Id: | NCT01345682 |
| Agent: | afatinib |
| Target: | Receptor proteintyrosine kinase erbB2 Epidermal growth factor receptor |
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase III, openlabel, multicentre, randomised trial |
| Key Patients Feature: | Eligible patients must be at least 18 years of age and have histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | methotrexate |
| Treatment Info: | pts are randomised 2:1 to oral afatinib (starting dose 40 mg once daily) or IV methotrexate (starting dose 40 mg/m(2) once weekly) administered as monotherapy with best supportive care until progression or intolerable adverse events. |
| Primary End Point: | PFS |
| Secondary End Point: | OS, ORR, healthrelated quality of life (HRQoL) and safety. |
| Patients Number: | recruting |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | pending |