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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04550260

This Phase III study involves 600 patients with locally advanced, unresectable ESCC, randomized 2:1 to receive durvalumab or placebo with dCRT. Eligibility includes confirmed ESCC, Stage II-IVA, ECOG PS 0-1, and adequate organ function. Interventions include durvalumab or placebo, cisplatin with fluorouracil or capecitabine, and radiation therapy. The primary goal is to evaluate progression-free survival.

Patient Parameters

Program Overview

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).

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.

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 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.

Locations

FACILITYZIPCITYSTATE
Research Site30308AtlantaGeorgia
Research Site40217LouisvilleKentucky
Research Site75390DallasTexas
Research Site22031FairfaxVirginia
Research Site26506MorgantownWest Virginia

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