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NCT04550260 Clinical Trial

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
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
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Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Not yet recruiting NCT05561699 - Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer N/A
Active, not recruiting NCT04543617 - A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy Phase 3
Recruiting NCT06190782 - Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor Phase 3
Completed NCT05557955 - Identification of Breath Biomarkers in Esophageal Cancer
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Not yet recruiting NCT03766178 - Study of Anti-PD-1 Antibody SHR-1210 Plus Nimotuzumab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT02913066 - S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT02399306 - Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma Phase 3
Completed NCT01605305 - Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer Phase 2
Not yet recruiting NCT05552651 - Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT05520619 - Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002) Phase 2
Terminated NCT03251417 - Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Phase 2
Recruiting NCT05990231 - Cadonilimab/Anlotinib in Locally Advanced or Relapsed/Metastatic ESCC Patients After Failure of PD-1 Combined With Platinum-containing Chemotherapy Phase 2
Recruiting NCT04644250 - Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT02916511 - Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma Phase 2
Terminated NCT04032704 - A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Phase 2