Clinical Trials /

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

NCT04550260

Description:

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).

Related Conditions:
  • Esophageal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: D910SC00001
  • NCT ID: NCT04550260

Conditions

  • Esophageal Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
DurvalumabMEDI4736Arm 1: Durvalumab + definitive CRT
PlaceboArm 2: Placebo + definitive CRT
cisplatin + fluorouracilArm 1: Durvalumab + definitive CRT
cisplatin + capecitabineArm 1: Durvalumab + definitive CRT

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm 1: Durvalumab + definitive CRTExperimentalDurvalumab + concurrent chemoradiation
  • Durvalumab
  • cisplatin + fluorouracil
  • cisplatin + capecitabine
Arm 2: Placebo + definitive CRTPlacebo ComparatorPlacebo + concurrent chemoradiation
  • Placebo
  • cisplatin + fluorouracil
  • cisplatin + capecitabine

Eligibility Criteria

        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 and has been deemed suitable for definitive chemoradiation therapy.

          -  Patients with at least 1 lesion that qualifies as a RECIST 1.1 Target Lesion at
             baseline.

          -  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, including but not limited to, chemotherapy and/or
             radiation therapy, immunotherapy, and investigational agents.

          -  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.
      
Maximum Eligible Age:130 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
Time Frame:up to approximately 56 months
Safety Issue:
Description: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

Measure:Overall survival (OS)
Time Frame:up to approximately 72 months
Safety Issue:
Description: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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Locally Advanced Unrespectable ESCC
  • PD-L1
  • Durvalumab

Last Updated

May 25, 2021