Clinical trial NCT04550260: Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
Official title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Locally Advanced unresectable ESCC
PD-L1
Durvalumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 640
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 is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

Detailed description: Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in PD-L1 High population.

Eligibility criteria: Inclusion Criteria:

* 18 years or older at the time of signing the ICF.
* Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).
* Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.
* Patients with at least an evaluable lesion per RECIST 1.1.
* Mandatory provision of available tumor tissue for PD-L1 expression analysis.
* ECOG PS 0 or 1.
* Adequate organ and marrow function.
* Life expectancy of more than 3 months.

Exclusion Criteria:

* Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.
* Prior anti-cancer treatment for ESCC.
* Patient with a great risk of perforation and massive bleeding.
* History of allogeneic organ transplantation.
* Active or prior documented autoimmune or inflammatory disorders.
* Uncontrolled intercurrent illness.
* History of another primary malignancy.
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Primary outcomes:
measure: Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
timeFrame: up to approximately 56 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to approximately 72 months
measure: Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
timeFrame: up to approximately 56 months
Other outcomes:
measure: Adverse events (AEs)
timeFrame: up to approximately 72 months
Locations:
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Brussel
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Barretos
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: São José do Rio Preto
country: Brazil
facility: Research Site
city: Vitoria
country: Brazil
facility: Research Site
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Anyang
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Bengbu
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changzhi
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Huai'an
country: China
facility: Research Site
city: Jieyang
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Liangyugang
country: China
facility: Research Site
city: Nantong
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Quanzhou
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Yangzhou
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zhenjiang
country: China
facility: Research Site
city: BESANCON Cedex
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rouen Cedex
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Hidaka-shi
country: Japan
facility: Research Site
city: Hirakata-shi
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Kashiwa
country: Japan
facility: Research Site
city: Kitaadachi-gun
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Kumamoto-shi
country: Japan
facility: Research Site
city: Maebashi-shi
country: Japan
facility: Research Site
city: Matsuyama-shi
country: Japan
facility: Research Site
city: Niigata-shi
country: Japan
facility: Research Site
city: Okayama-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Ota-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Chihuahua
country: Mexico
facility: Research Site
city: Cuernavaca
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Mérida
country: Mexico
facility: Research Site
city: Veracruz
country: Mexico
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Siedlce
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Sankt-Peterburg
country: Russian Federation
facility: Research Site
city: Tyumen
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Córdoba
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Mueang Chanthaburi
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Diyarbakir
country: Turkey
facility: Research Site
city: Erzurum
country: Turkey
facility: Research Site
city: Goztepe Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Van
country: Turkey
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Cancer Hospital of Chinese Academy of Medical Science
name: Luhua Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Hematology and Medical Oncology, Emory University
name: Nabil Saba, MD
role: PRINCIPAL_INVESTIGATOR
References: