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Clinical Trials in the UK / NCT05221840
Active, not recruiting Phase 3

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

NCT05221840 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-02-07
Last updated
2026-06-18

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

DurvalumabOleclumabMonalizumabPlacebo

Durvalumab: Durvalumab IV (intravenous infusion)

Oleclumab: Oleclumab IV (intravenous infusion)

Monalizumab: Monalizumab IV (intravenous infusion)

Placebo: Placebo IV (intravenous infusion)

Study summary

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
INCLUSION CRITERIA: * Participant must be ≥ 18 years at the time of screening. * Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease * Provision of a tumour tissue sample obtained prior to CRT * Documented tumour PD-L1 status by central lab * Documented EGFR and ALK wild-type status (local or central). * Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy * Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy * Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique. * WHO performance status of 0 or 1 at randomization * Adequate organ and marrow function EXCLUSION CRITERIA: * History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease. * Mixed small cell and non-small cell lung cancer histology. * Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. * Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. * Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia). * Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy. * History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization. * Active or prior documented autoimmune or inflammatory disorders (with exceptions) * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Primary outcome measure(s)

Trial sites (202)

FacilityCityRegionStatus
Research Site San Diego California
Research Site New Haven Connecticut
Research Site Stuart Florida
Research Site Urbana Illinois
Research Site New Albany Indiana
Research Site Lexington Kentucky
Research Site Louisville Kentucky
Research Site Annapolis Maryland
Research Site Baltimore Maryland
Research Site Baltimore Maryland
Research Site Bethesda Maryland
Research Site Grand Rapids Michigan
Research Site Duluth Minnesota
Research Site Billings Montana
Research Site Ridgewood New Jersey
Research Site Ithaca New York
Research Site Greensboro North Carolina
Research Site Cleveland Ohio
Research Site Cleveland Ohio
Research Site Maumee Ohio
Research Site Portland Oregon
Research Site Philadelphia Pennsylvania
Research Site York Pennsylvania
Research Site Sioux Falls South Dakota
Research Site Houston Texas
Research Site Charlottesville Virginia
Research Site Fairfax Virginia
Research Site Fredericksburg Virginia
Research Site Richmond Virginia
Research Site Richland Washington
Research Site Spokane Washington
Research Site Tacoma Washington
Research Site Milwaukee Wisconsin
Research Site Box Hill Australia
Research Site East Melbourne Australia
Research Site Elizabeth Vale Australia
Research Site Gosford Australia
Research Site Heidelberg Australia
Research Site Kogarah Australia
Research Site South Brisbane Australia

+ 162 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05221840 on ClinicalTrials.gov ↗ ← All trials in the UK