Entry Detail
| General information | |
| Database: | DB00361 |
| Objective: | afatinib |
| 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: | squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase III, openlabel, multicentre, randomisedtrial |
| Key Patients Feature: | ligible patients must be at least 18 years of age andhave histologically or cytologically confirmed squamouscell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and isnot amenable for salvage surgery or radiotherapy. Patientsare required to have documented progressive disease (PD)based on investigator assessment according to ResponseEvaluation Criteria in Solid Tumors (RECIST) followingreceipt of at least two cycles of cisplatin or carboplatin administered for R/M disease. Patients must have measurabledisease according to RECIST Version 1.1 and an ECOGperformance status of 0 or 1 at the time of randomisation |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:afatinib B: methotrexate |
| Treatment Info: | Patients with progressive disease after one firstline platinumbased chemotherapy 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, tumour response and safety. Healthrelated quality of life and biomarker assessments |
| Patients Number: | 474 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | If the LUXHead & Neck 1 trial meets its primary endpoint, it will demonstrate the ability of afatinib to elicit an improved treatment benefit versus a commonly used chemotherapy agent in the secondline treatment of R/M HNSCC patients who have failed on firstline platinumbased therapy, confirm the clinical efficacy of afatinib observed in the phase II proofofconcept study, and establish a new standard of care for this patient population. |
| 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: | protocol |