Clinical trial NCT02383966: Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Squamous Cell of Head and Neck
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)
timeFrame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
Secondary outcomes:
measure: Progression-free Survival (PFS) Time, as Assessed by the Investigator
timeFrame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
measure: Overall Survival (OS) Time
timeFrame: Time from date of randomization up to data cutoff (assessed up to 904 days)
measure: Best Overall Response Rate (ORR)
timeFrame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
measure: Disease Control Rate (DCR)
timeFrame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
measure: Duration of Response (DOR)
timeFrame: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
measure: 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
timeFrame: Time from date of randomization up to data cutoff (assessed up to 904 days)
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Research site
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Guo Y, Luo Y, Zhang Q, Huang X, Li Z, Shen L, Feng J, Sun Y, Yang K, Ge M, Zhu X, Wang L, Liu Y, He X, Bai C, Xue K, Zeng Y, Chang X, Chen W, Lin T. 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. Eur J Cancer. 2021 Oct;156:35-45. doi: 10.1016/j.ejca.2021.06.039. Epub 2021 Aug 18.