Esophageal Squamous Cell CarcinomaPhase 3KUNLUNNCT04550260
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
A Phase 3 study testing Durvalumab, cisplatin + fluorouracil and cisplatin + capecitabine in people with Esophageal Squamous Cell Carcinoma, run by AstraZeneca at 133 sites in 16 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Durvalumab, cisplatin + fluorouracil and cisplatin + capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 133 sitesin 16 countries
- Study dates
- 19 Oct 2020to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
133 sites in 16 countries.
133 sites in 16 countries
China29 sites
Research Site
Anyang, 455000
Research Site
Beijing, 100021
Research Site
Beijing, 100036
Research Site
Bengbu, 233004
Research Site
Changsha, 410003
Research Site
Changzhi, 46000
Research Site
Chengdu, 610042
Research Site
Chongqing, 400030
Research Site
Fuzhou, 350001
Research Site
Fuzhou, 350014
Research Site
Guangzhou, 510000
Research Site
Guangzhou, 510060
Research Site
Hangzhou
Research Site
Hefei, 230031
Research Site
Huai'an, 223300
Research Site
Jieyang, 522000
Research Site
Jinan, 250117
Research Site
Kunming, 650118
Research Site
Liangyugang, 222002
Research Site
Nantong, 226361
Research Site
Qingdao, 266042
Research Site
Quanzhou, 362000
Research Site
Shenzhen, 518116
Research Site
Tianjin, 300060
Research Site
Xi'an, 710061
Research Site
Xuzhou, 221000
Research Site
Yangzhou, 225001
Research Site
Zhengzhou, 450008
Research Site
Zhenjiang, 212002
Japan20 sites
Research Site
Bunkyō City, 113-8431
Research Site
Chūōku, 104-0045
Research Site
Hidaka-shi, 350-1298
Research Site
Hirakata-shi, 573-1191
Research Site
Hiroshima, 730-8518
Research Site
Kashiwa, 277-8577
Research Site
Kitaadachi-gun, 362-0806
Research Site
Kōtoku, 135-8550
Research Site
Kumamoto, 860-8556
Research Site
Maebashi, 371-8511
Research Site
Matsuyama, 791-0280
Research Site
Niigata, 951-8566
Research Site
Okayama, 700-8558
Research Site
Osaka, 541-8567
Research Site
Osaka, 545-8586
Research Site
Ota-shi, 373-8550
Research Site
Sendai, 980-8574
Research Site
Shinagawa-ku, 142-8666
Research Site
Yokohama, 232-0024
Research Site
Yokohama, 241-8515
Taiwan10 sites
Research Site
Changhua, 50006
Research Site
Kaohsiung City, 80756
Research Site
Kaohsiung City, 82445
Research Site
Kaohsiung City, 83301
Research Site
Taichung, 40443
Research Site
Taichung, 407
Research Site
Tainan, 710
Research Site
Taipei, 10002
Research Site
Taipei, 11217
Research Site
Taoyuan, 333
France8 sites
Research Site
Besançon, 25030
Research Site
Lille, 59000
Research Site
Lyon, 69008
Research Site
Montpellier, 34070
Research Site
Reims, 51100
Research Site
Rouen, 76031
Research Site
Strasbourg, 67033
Research Site
Villejuif, 94805
Russia8 sites
Research Site
Chelyabinsk, 454087
Research Site
Krasnodar, 350040
Research Site
Moscow, 115478
Research Site
Obninsk, 249031
Research Site
Saint Petersburg, 197758
Research Site
Tyumen, 6250041
Research Site
Ufa, 450054
Research Site
Yekaterinburg, 620905
Spain8 sites
Research Site
Barcelona, 8035
Research Site
Córdoba, 14004
Research Site
Madrid, 28007
Research Site
Madrid, 28034
Research Site
Madrid, 28046
Research Site
Pamplona, 31008
Research Site
Santander, 39008
Research Site
Zaragoza, 50009
Thailand8 sites
Research Site
Bangkok, 10210
Research Site
Bangkok, 10300
Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Chanthaburi, 22000
Research Site
Chiang Mai, 50200
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Brazil7 sites
Research Site
Barretos, 14784-400
Research Site
Fortaleza, 60430-230
Research Site
Porto Alegre, 90050-170
Research Site
Porto Alegre, 91350-200
Research Site
Rio de Janeiro, 20231-050
Research Site
São José do Rio Preto, 15090-000
Research Site
Vitória, 29043-260
Turkey (Türkiye)6 sites
Research Site
Ankara, 06800
Research Site
Diyarbakır, 21280
Research Site
Erzurum, 25240
Research Site
Goztepe Istanbul
Research Site
Izmir, 35575
Research Site
Van, 65080
United States5 sites
Research Site
Atlanta, Georgia, 30308
Research Site
Dallas, Texas, 75390
Research Site
Fairfax, Virginia, 22031
Research Site
Louisville, Kentucky, 40217
Research Site
Morgantown, West Virginia, 26506
Mexico5 sites
Research Site
Chihuahua City, 31210
Research Site
Cuernavaca, 62290
Research Site
Mérida, 97134
Research Site
Monterrey, 66220
Research Site
Veracruz, 91851
Poland5 sites
Research Site
Katowice, 40-074
Research Site
Krakow, 31-115
Research Site
Lodz, 90-513
Research Site
Siedlce, 08-110
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Warsaw, 02-034
South Korea5 sites
Research Site
Daegu, 41404
Research Site
Seoul, 06273
Research Site
Seoul, 06351
Research Site
Seoul, 138-736
Research Site
Suwon, 16247
Belgium4 sites
Research Site
Brussels, 1090
Research Site
Charleroi, 6060
Research Site
Liège, 4000
Research Site
Namur, 5000
Vietnam3 sites
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City
Canada2 sites
Research Site
Barrie, Ontario, L4M 6M2
Research Site
Greater Sudbury, Ontario, P3E 5J1
About this study
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)
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).
Read the 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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Durvalumab, Placebo, cisplatin + fluorouracil, cisplatin + capecitabine, Radiation
- Keywords
- Locally Advanced unresectable ESCC, PD-L1, Durvalumab
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Durvalumab intravenous infusion
PlaceboDrug
Durvalumab matching placebo for intravenous infusion
cisplatin + fluorouracilDrug
cisplatin + fluorouracil, as per Standard of Care
cisplatin + capecitabineDrug
cisplatin + capecitabine, as per Standard of Care
RadiationRadiation
50-64Gy in total
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Durvalumab + definitive CRT | Experimental | Durvalumab + concurrent chemoradiation Receives: Drug: Durvalumab; Drug: cisplatin + fluorouracil; Drug: cisplatin + capecitabine; Radiation: Radiation |
| Arm 2: Placebo + definitive CRT | Placebo comparator | Placebo + concurrent chemoradiation Receives: Drug: Placebo; Drug: cisplatin + fluorouracil; Drug: cisplatin + capecitabine; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to approximately 56 months
Secondary outcomes (2)
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
Measured: up to approximately 72 months
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
To assess the efficacy in terms of PFS in all randomized patients.
Measured: up to approximately 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start19 Oct 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luhua Wang, MD, Principal investigator, Cancer Hospital of Chinese Academy of Medical ScienceNabil Saba, MD, Principal investigator, Department of Hematology and Medical Oncology, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550260
- Sponsor's protocol ID
- D910SC00001
- Other IDs
- 2020-001001-22
- Acronym
- KUNLUN
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04550260
- Acronym / sponsor ID
- KUNLUN / D910SC00001
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Locally Advanced unresectable ESCC, PD-L1, Durvalumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 640 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Durvalumab + definitive CRT | Experimental | Drug: Durvalumab, Drug: cisplatin + fluorouracil, Drug: cisplatin + capecitabine, Radiation: RadiationDurvalumab + concurrent chemoradiation |
| Arm 2: Placebo + definitive CRT | Placebo comparator | Drug: Placebo, Drug: cisplatin + fluorouracil, Drug: cisplatin + capecitabine, Radiation: RadiationPlacebo + concurrent chemoradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736Durvalumab intravenous infusion | Drug | Arm 1: Durvalumab + definitive CRT |
| PlaceboDurvalumab matching placebo for intravenous infusion | Drug | Arm 2: Placebo + definitive CRT |
| cisplatin + fluorouracilcisplatin + fluorouracil, as per Standard of Care | Drug | Arm 1: Durvalumab + definitive CRT, Arm 2: Placebo + definitive CRT |
| cisplatin + capecitabinecisplatin + capecitabine, as per Standard of Care | Drug | Arm 1: Durvalumab + definitive CRT, Arm 2: Placebo + definitive CRT |
| Radiation50-64Gy in total | Radiation | Arm 1: Durvalumab + definitive CRT, Arm 2: Placebo + definitive CRT |
Primary outcome
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
2 secondary outcomes
Overall survival (OS)
Time frame: up to approximately 72 months
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Time frame: up to approximately 56 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luhua Wang, MD principal investigator
Cancer Hospital of Chinese Academy of Medical Science
Nabil Saba, MD principal investigator
Department of Hematology and Medical Oncology, Emory University
133 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durvalumab, cisplatin + fluorouracil and cisplatin + capecitabine in people with Esophageal Squamous Cell Carcinoma, run by AstraZeneca at 133 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 133 sites in China, Japan, Taiwan, France, Russia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR (time frame: up to approximately 56 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.