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

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ClinicalTrials.gov Identifier: NCT04550260
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : March 14, 2023
Information provided by (Responsible Party):

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
Esophageal Squamous Cell Carcinoma 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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 19, 2020
Estimated Primary Completion Date : November 28, 2025
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Arm 1: Durvalumab + definitive CRT
Durvalumab + concurrent chemoradiation
Drug: Durvalumab
Durvalumab intravenous infusion
Other Name: 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

Primary Outcome Measures :
  1. 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 and in patients with PD-L1 High tumors until disease progression

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 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) [ 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550260

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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Sponsors and Collaborators
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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
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04550260    
Other Study ID Numbers: D910SC00001
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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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
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological