Trials / Active Not Recruiting
Active Not RecruitingNCT04550260
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 640 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 PD-L1 High population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | Durvalumab intravenous infusion |
| DRUG | Placebo | Durvalumab matching placebo for intravenous infusion |
| DRUG | cisplatin + fluorouracil | cisplatin + fluorouracil, as per Standard of Care |
| DRUG | cisplatin + capecitabine | cisplatin + capecitabine, as per Standard of Care |
| RADIATION | Radiation | 50-64Gy in total |
Timeline
- Start date
- 2020-10-19
- Primary completion
- 2026-06-02
- Completion
- 2026-06-02
- First posted
- 2020-09-16
- Last updated
- 2026-01-29
Locations
133 sites across 16 countries: United States, Belgium, Brazil, Canada, China, France, Japan, Mexico, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04550260. Inclusion in this directory is not an endorsement.