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

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

Outcome

Met primary endpoint

registry analysis (superiority test); Afatinib 40 mg vs Methotrexate 40 mg; p = 0.0005; Hazard Ratio (HR) 0.627 (95% CI 0.478 to 0.823) NCT01856478 ↗

paper afatinib significantly decreased the risk of progression/death by 37% versus methotrexate (hazard ratio 0.63; 95% confidence interval 0.48-0.82; P = 0.0005; PMID 31501887 ↗

Publications

• Guo Y, Ahn MJ, Chan A, Wang CH, Kang JH, Kim SB, Bello M, Arora RS, Zhang Q, He X, Li P, Dechaphunkul A, Kumar V, Kamble K, Li W, Kandil A, Cohen EEW, Geng Y, Zografos E, Tang PZ. Afatinib versus methotrexate as second-line treatment in Asian patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 3): an open-label, randomised phase III trial. Ann Oncol. 2019 Nov 1;30(11):1831-1839. doi: 10.1093/annonc/mdz388.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afatinib	Small molecule	40 mg	Oral
Comparator	Methotrexate	Small molecule	40 mg/m2	Intravenous

Indications