Phase 3
Completed N=243
Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer
Source: ClinicalTrials.gov NCT02383966 ↗Enrolled (actual)
243
Serious AEs
28.0%
Results posted
Apr 2019
Primary outcomePrimary: Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC) — 5.5; 4.2 months
◆ Published Evidence
Established
63citations · ~13 / year
First-line treatment with chemotherapy plus cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety results of the randomised, phase III CHANGE-2 trial.
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.
Linked Publications
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First-line treatment with chemotherapy plus cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety results of the randomised, phase III CHANGE-2 trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.