Entry Detail
| General information | |
| Database: | DB00262 |
| Objective: | Afatinib, an irreversible ErbB family blocker, demonstrated antiproliferative activity in preclinical models and comparable clinical efficacy with cetuximab in a randomizedphase II trial in recurrent or metastatic HNSCC. LUXHead & Neck 2, a phase III study, will assess adjuvant afatinib versus placebo following chemoradiotherapy in primary unresected locoregionally advanced intermediatetohighrisk HNSCC. |
| Authors: | Burtness B, et al |
| Title: | Afatinib versus placebo as adjuvant therapy after chemoradiation in a doubleblind, phase III study (LUXHead & Neck 2) in patients with primary unresected, clinically intermediatetohighrisk head and neck cancer: study protocol for a randomized controlled trial. |
| Journal: | Trials. |
| Year: | 2014 |
| PMID: | 25432788 |
| Trial Design | |
| Clinical Trial Id: | NCT01345669 |
| Agent: | afatinib |
| Target: | Receptor proteintyrosine kinase erbB2 Epidermal growth factor receptor |
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced squamous cell carcinoma of the head and neck |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | afatinib as adjuvant therapy after chemoradiation |
| Study Type: | a doubleblind, phase III study (LUXHead & Neck II) |
| Key Patients Feature: | Patients with primary unresected locoregionally advanced HNSCC, in good clinical condition with unfavourable risk of recurrence, and no evidence of disease after chemoradiotherapy |
| Biomarker: | p16 status, ErbB ligands, ErbB receptor expression, EGFR mutational or activation status and ErbB downstream signalling markers |
| Biomark Analysis: | NA |
| Control Group Info: | placebo as adjuvant therapy after chemoradiation |
| Treatment Info: | After chemoradiotherapy, pts will be randomized 2:1 to oral oncedaily afatinib (40 mg starting dose) or placebo. Treatment will continue for 18 months or until recurrence or unacceptable adverse events occur. |
| Primary End Point: | duration of diseasefree survival; |
| Secondary End Point: | diseasefree survival rate at 2 years, overall survival, healthrelated quality of life and safety. |
| Patients Number: | 669 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | pending |
| Median OS A vs. C: | pending |
| Adverse Event(agent arm): | pending |
| Conclusions: | The trial was initiated in October 2011 and is currently recruiting patients,therefore the results are pending. |