Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer
CHANGE2
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
1 other identifier
interventional
243
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedStudy Start
First participant enrolled
July 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2018
CompletedResults Posted
Study results publicly available
April 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2021
CompletedMay 13, 2022
April 1, 2022
2.5 years
March 4, 2015
January 18, 2019
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)
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.
Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
Secondary Outcomes (6)
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)
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)
Disease Control Rate (DCR)
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)
- +1 more secondary outcomes
Study Arms (2)
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
EXPERIMENTALCisplatin/Carboplatin + 5-Flurouracil
ACTIVE COMPARATORInterventions
Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle.
Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.
Participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research site
Darmstadt, Germany
Related Publications (1)
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.
PMID: 34418665RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 10, 2015
Study Start
July 31, 2015
Primary Completion
January 19, 2018
Study Completion
December 20, 2021
Last Updated
May 13, 2022
Results First Posted
April 16, 2019
Record last verified: 2022-04