Clinical trial · Interventional
Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer
An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): MTD was established and patients completed 16 months safety f-up and response assessments. It is considered of limited value to follow patients for 3 years.
Summary
Brief summary (as posted)
The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy | Procedure | — | UNRESOLVED |
| zalutumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Zalutumumab 4 mg/kg
- description
- Zalutumumab 8 weekly infusions
- interventionNames
- Drug: zalutumumab
- Drug: cisplatin
- Procedure: Radiotherapy
- type
- EXPERIMENTAL
- label
- Zalutumumab 8 mg/kg
- description
- Zalutumumab 8 weekly infusions
- interventionNames
- Drug: zalutumumab
- Drug: cisplatin
- Procedure: Radiotherapy
- type
- EXPERIMENTAL
- label
- Zalutumumab 12 mg/kg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx Exclusion Criteria: * Prior treatment with radiotherapy in the head and neck area * Prior treatment with chemotherapy * Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors) * Previous surgery with curative intent for head and neck cancer
References
Publications (0)
Data not yet available