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) (KUNLUN)
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- STATUS
- Recruiting
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- End date
- Nov 30, 2026
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- participants needed
- 600
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- sponsor
- AstraZeneca
AstraZeneca Clinical Study Information Center
Primary Contact
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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 all randomized patients (intent-to-treat [ITT] population) and PFS in patients with PD-L1 high tumors (PD-L1 High population).
Details
| Condition | Esophageal Squamous Cell Carcinoma |
|---|---|
| Treatment | Placebo, Radiation, durvalumab, cisplatin + fluorouracil, cisplatin + capecitabine |
| Clinical Study Identifier | NCT04550260 |
| Sponsor | AstraZeneca |
| Last Modified on | 27 October 2022 |
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