drugset / Trial / NCT01856478

LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

NCT01856478

Phase 3 Completed 340 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.

Timeline

Start
2013-06-07
Primary completion
2018-08-22
Completion
2024-10-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 40 mg Oral
Comparator Methotrexate Small molecule 40 mg/m2 Intravenous