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

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04550260
Collaborator
(none)
600
Enrollment
155
Locations
2
Arms
73.4
Anticipated Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Durvalumab
  • Drug: Placebo
  • Drug: cisplatin + fluorouracil
  • Drug: cisplatin + capecitabine
  • Radiation: Radiation
 Phase 3

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 all randomized patients (intent-to-treat [ITT] population) and PFS in patients with PD-L1 high tumors (PD-L1 High population).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor, excluding supply chain management personnel, will remain blinded.
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Oct 19, 2020
Anticipated Primary Completion Date :
Nov 28, 2025
Anticipated Study Completion Date :
Nov 30, 2026

Arms and Interventions

Arm Intervention/Treatment
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: Placebo
    Durvalumab matching placebo for intravenous infusion

    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

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) per RECIST 1.1 as assessed by BICR [up to approximately 56 months]

      To assess the efficacy in terms of PFS in all randomized patients and in patients with PD-L1 High tumors until disease progression

    Secondary Outcome Measures

    1. Overall survival (OS) [up to approximately 72 months]

      To assess the efficacy in terms of OS in all randomized patients and in patients with PD-L1 High tumors until the date of death

    Other Outcome Measures

    1. Adverse events (AEs) [up to approximately 72 months]

      To assess the safety and tolerability profile of durvalumab + dCRT compared to placebo + dCRT in patients with ESCC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Tucson Arizona United States 85719
    2 Research Site Palm Springs California United States 92262
    3 Research Site Washington District of Columbia United States 20007
    4 Research Site Atlanta Georgia United States 30308
    5 Research Site Louisville Kentucky United States 40217
    6 Research Site Worcester Massachusetts United States 01655
    7 Research Site Detroit Michigan United States 48201
    8 Research Site Rochester New York United States 14642
    9 Research Site Memphis Tennessee United States 38104
    10 Research Site Dallas Texas United States 75390
    11 Research Site Houston Texas United States 77030
    12 Research Site Fairfax Virginia United States 22031
    13 Research Site Morgantown West Virginia United States 26506
    14 Research Site Brussel Belgium 1090
    15 Research Site Charleroi Belgium 6000
    16 Research Site Gent Belgium 9000
    17 Research Site Liège Belgium 4000
    18 Research Site Namur Belgium 5000
    19 Research Site Barretos Brazil 14784-400
    20 Research Site Fortaleza Brazil 60430-230
    21 Research Site Porto Alegre Brazil 90050-170
    22 Research Site Porto Alegre Brazil 91350-200
    23 Research Site Rio de Janeiro Brazil 20231-050
    24 Research Site São José do Rio Preto Brazil 15090-000
    25 Research Site São Paulo Brazil 04038-034
    26 Research Site Vitoria Brazil 29043-260
    27 Research Site Barrie Ontario Canada L4M 6M2
    28 Research Site Oshawa Ontario Canada L1G 2B9
    29 Research Site Sudbury Ontario Canada P3E 5J1
    30 Research Site Anyang China 455000
    31 Research Site Beijing China 100021
    32 Research Site Beijing China 100036
    33 Research Site Bengbu China 233060
    34 Research Site Changsha China 410013
    35 Research Site Chengdu China 610042
    36 Research Site Chongqing China 400030
    37 Research Site Fuzhou China 350001
    38 Research Site Fuzhou China 350014
    39 Research Site Guangzhou China 510000
    40 Research Site Guangzhou China 510060
    41 Research Site Guangzhou China 510062
    42 Research Site Hangzhou China 310052
    43 Research Site Hangzhou China
    44 Research Site Hefei China 230031
    45 Research Site Huai'an China 223300
    46 Research Site Jinan China 2501117
    47 Research Site Kunming China 650118
    48 Research Site Liangyugang China 222002
    49 Research Site Lu'an China 237005
    50 Research Site Nanjing China 210009
    51 Research Site Nantong China 226361
    52 Research Site Qingdao China 266042
    53 Research Site Quanzhou China 362000
    54 Research Site Shenzhen China 518116
    55 Research Site Shijiazhuang China 050020
    56 Research Site Xi'an China 710061
    57 Research Site Xuzhou China 221000
    58 Research Site Xuzhou China 221005
    59 Research Site Yangzhou China 225001
    60 Research Site Zhengzhou China 450000
    61 Research Site Zhengzhou China 450008
    62 Research Site Zhenjiang China 212002
    63 Research Site BESANCON Cedex France 25030
    64 Research Site Lille France 59000
    65 Research Site Lyon France 69008
    66 Research Site Montpellier France 34070
    67 Research Site Reims France 51100
    68 Research Site Rouen Cedex France 76031
    69 Research Site Strasbourg France 67033
    70 Research Site Villejuif Cedex France 94805
    71 Research Site Bunkyo-ku Japan 113-8431
    72 Research Site Chuo-ku Japan 104-0045
    73 Research Site Hidaka-shi Japan 350-1298
    74 Research Site Hirakata-shi Japan 573-1191
    75 Research Site Hiroshima-shi Japan 730-8518
    76 Research Site Kashiwa Japan 277-8577
    77 Research Site Kitaadachi-gun Japan 362-0806
    78 Research Site Koto-ku Japan 135-8550
    79 Research Site Kumamoto-shi Japan 860-8556
    80 Research Site Maebashi-shi Japan 371-8511
    81 Research Site Matsuyama-shi Japan 791-0280
    82 Research Site Niigata-shi Japan 951-8566
    83 Research Site Okayama-shi Japan 700-8558
    84 Research Site Osaka-shi Japan 541-8567
    85 Research Site Osaka-shi Japan 545-8586
    86 Research Site Ota-shi Japan 373-8550
    87 Research Site Sendai-shi Japan 980-8574
    88 Research Site Shinagawa-ku Japan 142-8666
    89 Research Site Yokohama-shi Japan 232-0024
    90 Research Site Yokohama-shi Japan 241-8515
    91 Research Site Daegu Korea, Republic of 41404
    92 Research Site Seoul Korea, Republic of 06273
    93 Research Site Seoul Korea, Republic of 06351
    94 Research Site Seoul Korea, Republic of 08308
    95 Research Site Seoul Korea, Republic of 138-736
    96 Research Site Suwon Korea, Republic of 16247
    97 Research Site Chihuahua Mexico 31210
    98 Research Site Monterrey Mexico 66220
    99 Research Site Mérida Mexico 97134
    100 Research Site San Luis Potosí Mexico 78250
    101 Research Site Den Haag Netherlands 2545 AA
    102 Research Site Nijmegen Netherlands 6525 GA
    103 Research Site Concepción Peru 12125
    104 Research Site Lima Peru 15036
    105 Research Site Lima Peru 15038
    106 Research Site Lima Peru Lima 32
    107 Research Site Katowice Poland 40-074
    108 Research Site Kraków Poland 31-115
    109 Research Site Siedlce Poland 08-110
    110 Research Site Warszawa Poland 02-034
    111 Research Site Łódź Poland 90-513
    112 Research Site Chelyabinsk Russian Federation 454087
    113 Research Site Ekaterinburg Russian Federation 620905
    114 Research Site Krasnodar Russian Federation 350040
    115 Research Site Moscow Russian Federation 115478
    116 Research Site Obninsk Russian Federation 249031
    117 Research Site Saint Petersburg Russian Federation 197758
    118 Research Site Sankt-Peterburg Russian Federation 197758
    119 Research Site Tyumen Russian Federation 6250041
    120 Research Site Ufa Russian Federation 450054
    121 Research Site Barcelona Spain 8035
    122 Research Site Córdoba Spain 14004
    123 Research Site Madrid Spain 28007
    124 Research Site Madrid Spain 28034
    125 Research Site Madrid Spain 28046
    126 Research Site Pamplona Spain 31008
    127 Research Site Santander Spain 39008
    128 Research Site Zaragoza Spain 50009
    129 Research Site Changhua Taiwan 50006
    130 Research Site Kaohsiung Taiwan 80756
    131 Research Site Kaohsiung Taiwan 824
    132 Research Site Kaohsiung Taiwan 83301
    133 Research Site Taichung Taiwan 40443
    134 Research Site Taichung Taiwan 407
    135 Research Site Tainan Taiwan 710
    136 Research Site Taipei Taiwan 10002
    137 Research Site Taipei Taiwan 11217
    138 Research Site Tao-Yuan Taiwan 333
    139 Research Site Bangkok Thailand 10210
    140 Research Site Bangkok Thailand 10300
    141 Research Site Bangkok Thailand 10330
    142 Research Site Bangkok Thailand 10400
    143 Research Site Chiang Mai Thailand 50200
    144 Research Site Hat Yai Thailand 90110
    145 Research Site Khon Kaen Thailand 40002
    146 Research Site Ankara Turkey 06800
    147 Research Site Diyarbakir Turkey 21280
    148 Research Site Erzurum Turkey 25240
    149 Research Site Goztepe Istanbul Turkey
    150 Research Site Izmir Turkey 35575
    151 Research Site Van Turkey 65080
    152 Research Site Ha Noi Vietnam 100000
    153 Research Site Hanoi Vietnam 100000
    154 Research Site Ho Chi Minh Vietnam 700000
    155 Research Site Ho Chi Minh Vietnam

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04550260
    Other Study ID Numbers:
    • D910SC00001
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    Locally Advanced Unrespectable ESCC
    PD-L1
    Durvalumab
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Esophageal Squamous Cell Carcinoma
    Cisplatin
    Fluorouracil
    Capecitabine
    Durvalumab

    Study Results

    No Results Posted as of Aug 3, 2022