Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
KUNLUN
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)
2 other identifiers
interventional
640
16 countries
133
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2020
Longer than P75 for phase_3
133 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedStudy Start
First participant enrolled
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 2, 2026
January 29, 2026
January 1, 2026
5.6 years
September 9, 2020
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Overall survival (OS)
up to approximately 72 months
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
up to approximately 56 months
Other Outcomes (1)
Adverse events (AEs)
up to approximately 72 months
Study Arms (2)
Arm 1: Durvalumab + definitive CRT
EXPERIMENTALDurvalumab + concurrent chemoradiation
Arm 2: Placebo + definitive CRT
PLACEBO COMPARATORPlacebo + concurrent chemoradiation
Interventions
cisplatin + fluorouracil, as per Standard of Care
cisplatin + capecitabine, as per Standard of Care
Durvalumab intravenous infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (133)
Research Site
Atlanta, Georgia, 30308, United States
Research Site
Louisville, Kentucky, 40217, United States
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Dallas, Texas, 75390, United States
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Fairfax, Virginia, 22031, United States
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Morgantown, West Virginia, 26506, United States
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Brussels, 1090, Belgium
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Charleroi, 6060, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Barretos, 14784-400, Brazil
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Fortaleza, 60430-230, Brazil
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Porto Alegre, 90050-170, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20231-050, Brazil
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São José do Rio Preto, 15090-000, Brazil
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Vitória, 29043-260, Brazil
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Barrie, Ontario, L4M 6M2, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Anyang, 455000, China
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Beijing, 100021, China
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Beijing, 100036, China
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Bengbu, 233004, China
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Changsha, 410013, China
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Changzhi, 46000, China
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Chengdu, 610042, China
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Chongqing, 400030, China
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Fuzhou, 350001, China
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Fuzhou, 350014, China
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Guangzhou, 510000, China
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Guangzhou, 510060, China
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Hangzhou, China
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Hefei, 230031, China
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Huai'an, 223300, China
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Jieyang, 522000, China
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Jinan, 250117, China
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Kunming, 650118, China
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Liangyugang, 222002, China
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Nantong, 226361, China
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Qingdao, 266042, China
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Quanzhou, 362000, China
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Shenzhen, 518116, China
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Tianjin, 300060, China
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Xi'an, 710061, China
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Xuzhou, 221000, China
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Yangzhou, 225001, China
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Zhengzhou, 450008, China
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Zhenjiang, 212002, China
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Besançon, 25030, France
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Lille, 59000, France
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Lyon, 69008, France
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Montpellier, 34070, France
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Reims, 51100, France
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Rouen, 76031, France
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Strasbourg, 67033, France
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Villejuif, 94805, France
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Bunkyō City, 113-8431, Japan
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Chūōku, 104-0045, Japan
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Hidaka-shi, 350-1298, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 730-8518, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Maebashi, 371-8511, Japan
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Matsuyama, 791-0280, Japan
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Niigata, 951-8566, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
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Ota-shi, 373-8550, Japan
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Sendai, 980-8574, Japan
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Shinagawa-ku, 142-8666, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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Chihuahua City, 31210, Mexico
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Cuernavaca, 62290, Mexico
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Mérida, 97134, Mexico
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Monterrey, 66220, Mexico
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Veracruz, 91851, Mexico
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Katowice, 40-074, Poland
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Krakow, 31-115, Poland
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Lodz, 90-513, Poland
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Siedlce, 08-110, Poland
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Warsaw, 02-034, Poland
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Chelyabinsk, 454087, Russia
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Krasnodar, 350040, Russia
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Moscow, 115478, Russia
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Obninsk, 249031, Russia
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Saint Petersburg, 197758, Russia
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Tyumen, 6250041, Russia
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Ufa, 450054, Russia
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Yekaterinburg, 620905, Russia
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Daegu, 41404, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Seoul, 138-736, South Korea
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Suwon, 16247, South Korea
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Barcelona, 8035, Spain
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Córdoba, 14004, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28046, Spain
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Pamplona, 31008, Spain
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Santander, 39008, Spain
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Zaragoza, 50009, Spain
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Changhua, 50006, Taiwan
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 82445, Taiwan
Research Site
Kaohsiung City, 83301, Taiwan
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Taichung, 40443, Taiwan
Research Site
Taichung, 407, Taiwan
Research Site
Tainan, 710, Taiwan
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Taipei, 10002, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taoyuan District, 333, Taiwan
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Bangkok, 10210, Thailand
Research Site
Bangkok, 10300, Thailand
Research Site
Bangkok, 10330, Thailand
Research Site
Bangkok, 10400, Thailand
Research Site
Chanthaburi, 22000, Thailand
Research Site
Chiang Mai, 50200, Thailand
Research Site
Hat Yai, 90110, Thailand
Research Site
Khon Kaen, 40002, Thailand
Research Site
Ankara, 06800, Turkey (Türkiye)
Research Site
Diyarbakır, 21280, Turkey (Türkiye)
Research Site
Erzurum, 25240, Turkey (Türkiye)
Research Site
Goztepe Istanbul, Turkey (Türkiye)
Research Site
Izmir, 35575, Turkey (Türkiye)
Research Site
Van, 65080, Turkey (Türkiye)
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Hanoi, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luhua Wang, MD
Cancer Hospital of Chinese Academy of Medical Science
- PRINCIPAL INVESTIGATOR
Nabil Saba, MD
Department of Hematology and Medical Oncology, Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor, excluding supply chain management personnel, will remain blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 16, 2020
Study Start
October 19, 2020
Primary Completion (Estimated)
June 2, 2026
Study Completion (Estimated)
June 2, 2026
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.