LUX-Head And 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

Status: Recruiting
Phase:
Diagnosis: Head and Neck Cancer
NCT ID: NCT01345669 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-028

 

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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Robert Haddad, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Lori Wirth, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Rosemary Costello, rcostello@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion criteria: 1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb 2. Unresected tumour prior to chemo-radiotherapy (CRT) 3. Concomitant CRT completed prior to randomisation 4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations 5. Eastern cooperative oncology group (ECOG) performance status 0 or 1 Exclusion criteria: 1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC 2. 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 3. 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 4. Known pre-existing Interstitial Lung Disease (ILD) 5. Pregnancy or breast feeding
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