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

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: cisplatin + fluorouracil; Drug: cisplatin + capecitabine; Radiation: Radiation; Drug: Placebo; Drug: Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04550260

D910SC00001

2020-001001-22 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 640 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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640 participants in 2 patient groups, including a placebo group

Arm 1: Durvalumab + definitive CRT

Experimental group

Description:

Durvalumab + concurrent chemoradiation

Treatment:

Drug: Durvalumab

Radiation: Radiation

Drug: cisplatin + capecitabine

Drug: cisplatin + fluorouracil

Arm 2: Placebo + definitive CRT

Placebo Comparator group

Description:

Placebo + concurrent chemoradiation

Treatment:

Drug: Placebo

Radiation: Radiation

Drug: cisplatin + capecitabine

Drug: cisplatin + fluorouracil