Clinical trial details

A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

Identifier

D9078C00001

Sponsor

ASTRAZENECA FARMACÉUTICA SPAIN, S.A.

Principal Investigator

NURIA PARDO ARANDA

Service

Oncology

Study details

Tumor type: LUNG-NSCLC
Stage: Early/Locally advanced
Main Investigational Agent : Immunotherapy
Phase: III
Randomization: Randomized

Molecular details

Biomarker: ALK wt; EGFR wt; PD-L1 known-stat
Biomarker criteria: Mandatory
Prescreening: Local/Central
Additional study population requirements: Documented tumour PD-L1 status by central lab Documented EGFR and ALK wild-type status (local or central).

Drug details

Arm A: Durvalumab and Monalizumab
Arm B: Durvalumab and Oleclumab
Arm C: Durvalumab and Placebo

Links

Clinical Trials GOV (NCT identifier): NCT05221840
EU Clinical Trials Register (eudraCT Identifier): 2021-004346-37