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) (KUNLUN)

  • End date
    Nov 30, 2026
  • participants needed
  • sponsor
Updated on 27 October 2022
AstraZeneca Clinical Study Information Center
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squamous cell carcinoma


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).


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).

Condition Esophageal Squamous Cell Carcinoma
Treatment Placebo, Radiation, durvalumab, cisplatin + fluorouracil, cisplatin + capecitabine
Clinical Study IdentifierNCT04550260
Last Modified on27 October 2022


Yes No Not Sure

Inclusion Criteria

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
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