Clinical Trials List
2020-08-14 - 2027-07-24
Phase III
Recruiting8
Terminated2
A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
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Trial Applicant
Syneos Health
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Sponsor
Debiopharm International S.A.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 胡育文 無
- Tsung-Lun Lee 無
- 黃品逸 無
- Chia-Fan Chang 無
- Sheng-Yu Chen 無
- Mu-Hsin Chang 無
- 朱本元 無
- Yuan-Hung Wu 無
- Ling-Wei Wang 無
- 戴世光 無
- 陳盛裕 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsiang-Fong Kao Division of Hematology & Oncology
- YA-FANG CHEN Division of Radiology
- 陳婉瑜 Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- HUAI-CHENG HUANG Division of Hematology & Oncology
- 王駿瑋 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Lung Hsu 無
- Tuan Jen Fang 無
- 林倩伃 無
- 葉智華 無
- 李立昂 無
- Hung-Ming Wang 無
- 黃祥富 無
- Kai-Ping Chang 無
- Tsung-Yu Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzu-Yen Huang 無
- 湯人仰 無
- 曾良鵬 無
- Chih-Jen Huang 無
- 蔡宗鎰 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃泰霖 無
- Jen-Yu Cheng 無
- 李易濰 無
- 郭明濬 無
- 陳彥仰 無
- 吳佳哲 無
- 黃詩喻 無
- Shau-Hsuan Li 無
- 黃永成 無
- SI蘇祐立 CV_10Dec2021 無
- 劉建廷 無
- 陳彥豪 無
- 賴香蘭 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Event-Free Survival (EFS) [ Time Frame: Up to 5 years ]
EFS is the time from the date of randomization to the date of first record of disease progression or death.
Secondary Outcome Measures :
Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]
PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)
Overall survival (OS) [ Time Frame: Up to 5 years ]
OS is the time from randomization to death due to any cause.
Locoregional Control (LRC) [ Time Frame: From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years) ]
Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure [ Time Frame: From signed informed consent to EOS (within 6.8 years) ]
Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom [ Time Frame: Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years) ]
Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)
Changes from Baseline in Swallowing and Pain Symptoms [ Time Frame: Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years) ]
Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)
Inclution Criteria
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb according to the American Joint Committee on Cancer(AJCC))/Classification of malignant tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant metastasis (TNM) Staging System, 8th Ed.) suitable for definitive ChemoRadiotherapy (CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx
For OroPharyngeal Cancer (OPC) participants, primary tumors must be human papillomavirus (HPV)-negative as determined by expression using immunohistochemistry
Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1
Peripheral neuropathy < grade 2
Adequate hematologic, renal and hepatic function
Exclusion Criteria
Primary tumor of nasopharyngeal, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site
Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.)
Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents
Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0 g/dL
Known allergy to Debio 1143, cisplatin or any excipient known to be present in Debio1143 or in the placebo formulation.
The Estimated Number of Participants
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Taiwan
62 participants
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Global
875 participants
