Phase 3
N=483
LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
Head and Neck Neoplasms · Carcinoma, Squamous Cell
Bottom Line
View on ClinicalTrials.gov: NCT01345682 ↗Enrolled (actual)
483
Serious AEs
50.2%
Results posted
Apr 2015
Primary outcome: Primary: Progression-free Survival (PFS) Based on Central Independent Review — 2.63; 1.74 months — p=0.0257
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Afatinib (Drug); Methotrexate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Based on Central Independent Review |
2.63; 1.74 | 0.0257 sig |
| SECONDARY Overall Survival (OS) |
6.87; 6.01 | 0.6755 |
| SECONDARY Objective Response (OR) |
10.2; 5.6 | 0.1010 |
| SECONDARY Disease Control (DC) |
49.1; 38.5 | 0.0353 sig |
| SECONDARY Tumour Shrinkage |
16.5; 21.1; 24.2; 31.1; 23.6; 16.1 | — |
| SECONDARY Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time |
11.8; 16.2 | 0.0300 sig |
| SECONDARY Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time |
20.0; 20.1 | 0.9773 |
| SECONDARY Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time |
28.7; 28.2 | 0.7767 |
| SECONDARY Status Change in Pain Scale |
26.4; 23.1; 32.1; 31.6; 41.5; 45.3 | 0.494 |
| SECONDARY Status Change in Swallowing Scale |
26.1; 23.2; 34.2; 29.5; 39.7; 47.3 | 0.584 |
| SECONDARY Status Change in Global Health Status Scale |
30.3; 29.1; 26.6; 25.6; 43.1; 45.3 | 0.816 |
| SECONDARY Time to Deterioration in Pain |
3.02; 2.30 | 0.0217 sig |
| SECONDARY Time to Deterioration in Swallowing |
3.75; 2.10 | 0.0040 sig |
| SECONDARY Time to Deterioration in Global Health Status |
3.25; 2.69 | 0.0268 sig |
Summary
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
Eligibility Criteria
Inclusion criteria
- Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
- Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
- Measurable disease according to RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion criteria
- Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
- Any other than one previous platinum based systemic regimen given for R/M disease
- Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
- Pregnancy or breast feeding
Data sourced from ClinicalTrials.gov (NCT01345682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.