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).
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
| Drug | Synonyms | Arms |
|---|
| Durvalumab | MEDI4736 | Arm 1: Durvalumab + definitive CRT |
| Placebo | | Arm 2: Placebo + definitive CRT |
| cisplatin + fluorouracil | | Arm 1: Durvalumab + definitive CRT |
| cisplatin + capecitabine | | Arm 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
| Name | Type | Description | Interventions |
|---|
| Arm 1: Durvalumab + definitive CRT | Experimental | Durvalumab + concurrent chemoradiation | - Durvalumab
- cisplatin + fluorouracil
- cisplatin + capecitabine
|
| Arm 2: Placebo + definitive CRT | Placebo Comparator | Placebo + 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
September 1, 2021
