Phase 3
N=243
Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer
Carcinoma, Squamous Cell of Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT02383966 ↗Enrolled (actual)
243
Serious AEs
28.0%
Results posted
Apr 2019
Primary outcome: Primary: Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC) — 5.5; 4.2 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cetuximab (Drug); Cisplatin/Carboplatin (Drug); 5-fluorouracil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC) |
5.5; 4.2 | — |
| SECONDARY Progression-free Survival (PFS) Time, as Assessed by the Investigator |
5.5; 4.6 | — |
| SECONDARY Overall Survival (OS) Time |
10.2; 8.4 | — |
| SECONDARY Best Overall Response Rate (ORR) |
50; 26.6 | — |
| SECONDARY Disease Control Rate (DCR) |
75.6; 59.5 | — |
| SECONDARY Duration of Response (DOR) |
18.1; 13.9 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Emergent Adverse Events Leading to Death and AEs Leading to Discontinuation |
163; 75; 46; 21; 11; 8 | — |
Summary
This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of SCCHN
- Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment
- Presence of at least 1 measurable lesion according to RECIST Version 1.1
- Signed written informed consent before any trial-related activities are carried out
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Other protocol-defined inclusion criteria could apply
Exclusion Criteria
- Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease, that was completed within 6 months before randomization
- Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before trial entry
- Previous treatment with monoclonal antibody or signal transduction inhibitors targeting epidermal growth factor receptor
- Nasopharyngeal carcinoma
- Known central nervous system metastasis and/or leptomeningeal disease
- Medical or psychological condition that would not permit the participant to complete the trial or sign informed consent
- Legal incapacity or limited legal capacity
- Other protocol-defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02383966). 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.