LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Head and Neck Neoplasms

In brief

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

Key facts

Study ID: NCT01345669
Run by: Boehringer Ingelheim
People needed: 617
Starts: 2011-10-17
Expected to finish: 2016-09-12
Last updated by the study team: 2017-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
Unresected tumour prior to chemo-radiotherapy (CRT)
Concomitant CRT completed prior to randomisation
After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
Eastern cooperative oncology group (ECOG) performance status 0 or 1

You may not qualify if…

Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
Known pre-existing Interstitial Lung Disease (ILD)
Pregnancy or breast feeding

Where it is running

1200.131.00181 Boehringer Ingelheim Investigational Site — Orange, California, United States
1200.131.00177 Boehringer Ingelheim Investigational Site — Aurora, Colorado, United States
1200.131.00185 Boehringer Ingelheim Investigational Site — New Haven, Connecticut, United States
1200.131.00173 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
1200.131.00176 Boehringer Ingelheim Investigational Site — Boston, Massachusetts, United States
1200.131.00182 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
1200.131.00175 Boehringer Ingelheim Investigational Site — Lebanon, New Hampshire, United States
1200.131.00179 Boehringer Ingelheim Investigational Site — Stony Brook, New York, United States
1200.131.00188 Boehringer Ingelheim Investigational Site — The Bronx, New York, United States
1200.131.10200 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
1200.131.00172 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
1200.131.00184 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
1200.131.00198 Boehringer Ingelheim Investigational Site — Spokane Valley, Washington, United States
1200.131.00183 Boehringer Ingelheim Investigational Site — Wenatchee, Washington, United States
1200.131.05451 Boehringer Ingelheim Investigational Site — Ciudad Autonoma de Bs As, Argentina
1200.131.05457 Boehringer Ingelheim Investigational Site — Córdoba, Argentina
1200.131.05458 Boehringer Ingelheim Investigational Site — San Miguel de Tucumán, Argentina
1200.131.05452 Boehringer Ingelheim Investigational Site — Santa Fe, Argentina
1200.131.05453 Boehringer Ingelheim Investigational Site — Villa Domínico, Argentina
1200.131.06151 Boehringer Ingelheim Investigational Site — Wooloongabba, Queensland, Australia
1200.131.04353 Boehringer Ingelheim Investigational Site — Leoben, Austria
1200.131.04357 Boehringer Ingelheim Investigational Site — Linz, Austria
1200.131.04355 Boehringer Ingelheim Investigational Site — Salzburg, Austria
1200.131.04351 Boehringer Ingelheim Investigational Site — Vienna, Austria
1200.131.00171 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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