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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506413-22-00
Acronym
D910SC00001/KUNLUN
Enrollment
48
Registered
2024-04-08
Start date
2021-03-31
Completion date
Unknown
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Brief summary

PFS using BICR assessments according to RECIST 1.1 in patients with PD-L1 TAP≥1% tumors

Detailed description

PFS using BICR assessments according to RECIST 1.1 in all randomized patients OS, OS36, PFS2 APF24,ORR, DoR, DCR and TTP per RECIST 1.1 as assessed by BICR in all randomized patients and in patients with PD-L1 TAP≥1% tumors Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by EORTC QLQ-C30 and QLQ-OES18 Concentration of durvalumab in blood ADA in all randomized patients

Interventions

DRUGThe Placebo is formulated as 26 mM histidine/histidine-HCl
DRUG275 mM trehalose dihydrate
DRUG0.02% (w/v) polysorbate 80
DRUGpH 6.0.
DRUGCapecitabine Accord 500 mg film-coated tablets
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGCapecitabine Accord 150 mg film-coated tablets
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGMycophenolate Mofetil Accord 250 mg capsules
DRUGInflectra 100 mg powder for concentrate for solution for infusion
DRUGFluorouracil Injection
DRUG50 mg/ml
DRUGsolution for injection

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PFS using BICR assessments according to RECIST 1.1 in patients with PD-L1 TAP≥1% tumors—

Secondary

MeasureTime frame
PFS using BICR assessments according to RECIST 1.1 in all randomized patients OS, OS36, PFS2 APF24,ORR, DoR, DCR and TTP per RECIST 1.1 as assessed by BICR in all randomized patients and in patients with PD-L1 TAP≥1% tumors Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by EORTC QLQ-C30 and QLQ-OES18 Concentration of durvalumab in blood ADA in all randomized patients—

Countries

Belgium, France, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026