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

May 12, 2026 updated by: AstraZeneca

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
640

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Research Site
      • Charleroi, Belgium, 6060
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Namur, Belgium, 5000
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Fortaleza, Brazil, 60430-230
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 90050-170
        • Research Site
      • Rio de Janeiro, Brazil, 20231-050
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • Vitória, Brazil, 29043-260
        • Research Site
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Research Site
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Research Site
  • China
      • Anyang, China, 455000
        • Research Site
      • Beijing, China, 100021
        • Research Site
      • Beijing, China, 100036
        • Research Site
      • Bengbu, China, 233004
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Changzhi, China, 46000
        • Research Site
      • Chengdu, China, 610042
        • Research Site
      • Chongqing, China, 400030
        • Research Site
      • Fuzhou, China, 350014
        • Research Site
      • Fuzhou, China, 350001
        • Research Site
      • Guangzhou, China, 510000
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Hangzhou, China
        • Research Site
      • Hefei, China, 230031
        • Research Site
      • Huai'an, China, 223300
        • Research Site
      • Jieyang, China, 522000
        • Research Site
      • Jinan, China, 250117
        • Research Site
      • Kunming, China, 650118
        • Research Site
      • Liangyugang, China, 222002
        • Research Site
      • Nantong, China, 226361
        • Research Site
      • Qingdao, China, 266042
        • Research Site
      • Quanzhou, China, 362000
        • Research Site
      • Shenzhen, China, 518116
        • Research Site
      • Tianjin, China, 300060
        • Research Site
      • Xi'an, China, 710061
        • Research Site
      • Xuzhou, China, 221000
        • Research Site
      • Yangzhou, China, 225001
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
      • Zhenjiang, China, 212002
        • Research Site
  • France
      • Besançon, France, 25030
        • Research Site
      • Lille, France, 59000
        • Research Site
      • Lyon, France, 69008
        • Research Site
      • Montpellier, France, 34070
        • Research Site
      • Reims, France, 51100
        • Research Site
      • Rouen, France, 76031
        • Research Site
      • Strasbourg, France, 67033
        • Research Site
      • Villejuif, France, 94805
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Research Site
      • Chūōku, Japan, 104-0045
        • Research Site
      • Hidaka-shi, Japan, 350-1298
        • Research Site
      • Hirakata-shi, Japan, 573-1191
        • Research Site
      • Hiroshima, Japan, 730-8518
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Research Site
      • Kitaadachi-gun, Japan, 362-0806
        • Research Site
      • Kumamoto, Japan, 860-8556
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Maebashi, Japan, 371-8511
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Research Site
      • Niigata, Japan, 951-8566
        • Research Site
      • Okayama, Japan, 700-8558
        • Research Site
      • Osaka, Japan, 545-8586
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Ota-shi, Japan, 373-8550
        • Research Site
      • Sendai, Japan, 980-8574
        • Research Site
      • Shinagawa-ku, Japan, 142-8666
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
      • Yokohama, Japan, 232-0024
        • Research Site
  • Mexico
      • Chihuahua City, Mexico, 31210
        • Research Site
      • Cuernavaca, Mexico, 62290
        • Research Site
      • Monterrey, Mexico, 66220
        • Research Site
      • Mérida, Mexico, 97134
        • Research Site
      • Veracruz, Mexico, 91851
        • Research Site
  • Poland
      • Katowice, Poland, 40-074
        • Research Site
      • Krakow, Poland, 31-115
        • Research Site
      • Lodz, Poland, 90-513
        • Research Site
      • Siedlce, Poland, 08-110
        • Research Site
      • Warsaw, Poland, 02-034
        • Research Site
  • Russia
      • Chelyabinsk, Russia, 454087
        • Research Site
      • Krasnodar, Russia, 350040
        • Research Site
      • Moscow, Russia, 115478
        • Research Site
      • Obninsk, Russia, 249031
        • Research Site
      • Saint Petersburg, Russia, 197758
        • Research Site
      • Tyumen, Russia, 6250041
        • Research Site
      • Ufa, Russia, 450054
        • Research Site
      • Yekaterinburg, Russia, 620905
        • Research Site
  • South Korea
      • Daegu, South Korea, 41404
        • Research Site
      • Seoul, South Korea, 06273
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 138-736
        • Research Site
      • Suwon, South Korea, 16247
        • Research Site
  • Spain
      • Barcelona, Spain, 8035
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • Santander, Spain, 39008
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Research Site
      • Kaohsiung City, Taiwan, 82445
        • Research Site
      • Kaohsiung City, Taiwan, 83301
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Research Site
      • Taichung, Taiwan, 40443
        • Research Site
      • Taichung, Taiwan, 407
        • Research Site
      • Tainan, Taiwan, 710
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10210
        • Research Site
      • Bangkok, Thailand, 10300
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Chanthaburi, Thailand, 22000
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Research Site
      • Diyarbakır, Turkey (Türkiye), 21280
        • Research Site
      • Erzurum, Turkey (Türkiye), 25240
        • Research Site
      • Goztepe Istanbul, Turkey (Türkiye)
        • Research Site
      • Izmir, Turkey (Türkiye), 35575
        • Research Site
      • Van, Turkey (Türkiye), 65080
        • Research Site
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh City, Vietnam
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Durvalumab + definitive CRT
Durvalumab + concurrent chemoradiation
Drug: Durvalumab
Durvalumab intravenous infusion
Other Names:
  • MEDI4736
Drug: cisplatin + fluorouracil
cisplatin + fluorouracil, as per Standard of Care
Drug: cisplatin + capecitabine
cisplatin + capecitabine, as per Standard of Care
Radiation: Radiation
50-64Gy in total
Placebo Comparator: Arm 2: Placebo + definitive CRT
Placebo + concurrent chemoradiation
Drug: cisplatin + fluorouracil
cisplatin + fluorouracil, as per Standard of Care
Drug: cisplatin + capecitabine
cisplatin + capecitabine, as per Standard of Care
Radiation: Radiation
50-64Gy in total
Drug: Placebo
Durvalumab matching placebo for intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Time Frame: up to approximately 56 months
To assess the efficacy in terms of PFS in PD-L1 High population
up to approximately 56 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to approximately 72 months
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
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Time Frame: up to approximately 56 months
To assess the efficacy in terms of PFS in all randomized patients.
up to approximately 56 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: up to approximately 72 months
To assess the safety and tolerability profile of durvalumab + dCRT compared to placebo + dCRT in patients with ESCC
up to approximately 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D910SC00001
  • 2020-001001-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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