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

Phase 3

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: afatinib; Drug: methotrexate

• Registration Number: NCT01856478
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-17
• Study Start: 2013-06-07
• Primary Completion: 2018-08-22
• Study Completion: 2024-10-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
afatinib	afatinib	oral intake, once daily
methotrexate	methotrexate	intravenous bolus injection, once weekly

Primary Outcome Measures

Name	Time	Method
progression free survival (PFS), defined as the time from the date of randomization to the date of progression evaluated according to RECIST 1.1 or to the date of death, whichever occurs first	up to 2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS), defined as the time from the date of randomization to the date of death (regardless of the cause of death)	up to 3 years
Objective response defined as complete response (CR) or partial response (PR) determined by RECIST 1.1 according to the best response to study medication	up to 2 years
Health related quality of life (HRQOL) will be assessed based on patient-reported questionaires	up to 2 years

Trial Locations

Locations (52)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, China

Cancer Hospital of Chinese Academy of Medical Science; 🇨🇳 Beijing, China

Navy General Hospital; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital Of Bengbu Medical College; 🇨🇳 Bengbu, China

The First Hospital of Jilin University; 🇨🇳 Changchun, China

Sichuan Cancer Hospital; 🇨🇳 Chengdu, China

West China Hospital; 🇨🇳 Chengdu, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, China

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