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)

Studio Clinico

Patologia: Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Mantenimento

Criteri di inclusione: 

- 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 p16 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

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Debio 1143

Trattamento di controllo: 

Placebo

Obiettivi primari dello studio: 

The primary objective of the study is to demonstrate superior efficacy of Debio 1143 vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

Note generali: 

Linea di trattamento: setting curativo

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-000377-25

Data di inserimento: 12.05.2021

Data di aggiornamento: 26.09.2022

Promotore

Debiopharm International SA

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei tumori - SC Oncologia medica 3 'Tumori testa-collo', Milano

Riferimento: Prof.ssa Lisa Licitra

Telefono: 0223902150

Email: lisa.licitra@istitutotumori.mi.it

Localita: Milano