Clinical trial · Interventional
Zalutumumab in Patients With Non-curable Head and Neck Cancer
An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy
NCT00382031CI-TRIAL-00012388completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Squamous Cell Cancer | Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| Zalutumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- zalutumumab
- description
- Zalutumumab in combination with Best Supportive Care
- interventionNames
- Drug: Zalutumumab
- Other: Control
- type
- OTHER
- label
- Control
- description
- Best Supportive Care
- interventionNames
- Other: Control
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- From randomization until death
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males and Females age ≥ 18 years 2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy 3. Failure to at least one course of standard platinum-based chemotherapy Exclusion Criteria: 1. Three or more chemotherapy regimens other than platinum-based chemotherapy 2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors 3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
References
Publications (1)
- DERIVEDMachiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sorensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. doi: 10.1016/S1470-2045(11)70034-1. Epub 2011 Mar 4. PMID 21377930