A Multicenter, Randomized, Open-label, Phase III Trial to Assess Efficacy and Safety of Cetuximab When Given in Combination With Cisplatin Plus 5 Fluorouracil Versus Cisplatin Plus 5-fluorouracil Alone for the First-line Treatment of Chinese Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Overview
- Phase
- Phase 3
- Intervention
- Cetuximab
- Conditions
- Carcinoma, Squamous Cell of Head and Neck
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 243
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
Intervention: Cetuximab
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
Intervention: Cisplatin/Carboplatin
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
Intervention: 5-fluorouracil
Cisplatin/Carboplatin + 5-Flurouracil
Intervention: Cisplatin/Carboplatin
Cisplatin/Carboplatin + 5-Flurouracil
Intervention: 5-fluorouracil
Outcomes
Primary Outcomes
Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)
Time Frame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
Secondary Outcomes
- Best Overall Response Rate (ORR)(Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days))
- Duration of Response (DOR)(Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days))
- Progression-free Survival (PFS) Time, as Assessed by the Investigator(Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days))
- Overall Survival (OS) Time(Time from date of randomization up to data cutoff (assessed up to 904 days))
- Disease Control Rate (DCR)(Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days))
- 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(Time from date of randomization up to data cutoff (assessed up to 904 days))