Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC

Esophageal Squamous Cell Carcinoma Clinical Trial

— KUNLUN  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04550260
• Other study ID #: D910SC00001
• Secondary ID: 2020-001001-22
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 19, 2020
• Est. completion date: November 30, 2026

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 640
• Est. completion date: November 30, 2026
• Est. primary completion date: November 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Durvalumab
Durvalumab intravenous infusion
• Placebo
Durvalumab matching placebo for intravenous infusion
• cisplatin + fluorouracil
cisplatin + fluorouracil, as per Standard of Care
• cisplatin + capecitabine
cisplatin + capecitabine, as per Standard of Care

Radiation:
• Radiation
50-64Gy in total

Locations

Country	Name	City	State
Belgium	Research Site	Brussel
Belgium	Research Site	Charleroi
Belgium	Research Site	Liège
Belgium	Research Site	Namur
Brazil	Research Site	Barretos
Brazil	Research Site	Fortaleza
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	São José do Rio Preto
Brazil	Research Site	Vitoria
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Sudbury	Ontario
China	Research Site	Anyang
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Bengbu
China	Research Site	Changsha
China	Research Site	Changzhi
China	Research Site	Chengdu
China	Research Site	Chongqing
China	Research Site	Fuzhou
China	Research Site	Fuzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Hefei
China	Research Site	Huai'an
China	Research Site	Jieyang
China	Research Site	Jinan
China	Research Site	Kunming
China	Research Site	Liangyugang
China	Research Site	Nantong
China	Research Site	Qingdao
China	Research Site	Quanzhou
China	Research Site	Shenzhen
China	Research Site	Tianjin
China	Research Site	Xi'an
China	Research Site	Xuzhou
China	Research Site	Yangzhou
China	Research Site	Zhengzhou
China	Research Site	Zhenjiang
France	Research Site	BESANCON Cedex
France	Research Site	Lille
France	Research Site	Lyon
France	Research Site	Montpellier
France	Research Site	Reims
France	Research Site	Rouen Cedex
France	Research Site	Strasbourg
France	Research Site	Villejuif Cedex
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Hidaka-shi
Japan	Research Site	Hirakata-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Kashiwa
Japan	Research Site	Kitaadachi-gun
Japan	Research Site	Koto-ku
Japan	Research Site	Kumamoto-shi
Japan	Research Site	Maebashi-shi
Japan	Research Site	Matsuyama-shi
Japan	Research Site	Niigata-shi
Japan	Research Site	Okayama-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Ota-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon
Mexico	Research Site	Chihuahua
Mexico	Research Site	Cuernavaca
Mexico	Research Site	Mérida
Mexico	Research Site	Monterrey
Mexico	Research Site	Veracruz
Poland	Research Site	Katowice
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Siedlce
Poland	Research Site	Warszawa
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Sankt-Peterburg
Russian Federation	Research Site	Tyumen
Russian Federation	Research Site	Ufa
Spain	Research Site	Barcelona
Spain	Research Site	Córdoba
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Pamplona
Spain	Research Site	Santander
Spain	Research Site	Zaragoza
Taiwan	Research Site	Changhua
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Tao-Yuan
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Thailand	Research Site	Hat Yai
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Mueang Chanthaburi
Turkey	Research Site	Ankara
Turkey	Research Site	Diyarbakir
Turkey	Research Site	Erzurum
Turkey	Research Site	Goztepe Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Van
United States	Research Site	Atlanta	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Fairfax	Virginia
United States	Research Site	Louisville	Kentucky
United States	Research Site	Morgantown	West Virginia
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Belgium,  Brazil,  Canada,  China,  France,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events (AEs)	To assess the safety and tolerability profile of durvalumab + dCRT compared to placebo + dCRT in patients with ESCC	up to approximately 72 months
Primary	Progression free survival (PFS) per RECIST 1.1 as assessed by BICR	To assess the efficacy in terms of PFS in PD-L1 High population	up to approximately 56 months
Secondary	Overall survival (OS)	To assess the efficacy in terms of OS in all randomized patients and in PD-L1 High population until the date of death	up to approximately 72 months
Secondary	Progression free survival (PFS) per RECIST 1.1 as assessed by BICR	To assess the efficacy in terms of PFS in all randomized patients.	up to approximately 56 months