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
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)
Progression Free Surival (PFS) — Up to 5 years after first patient randomized. Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
Trial sites (202)
Facility
City
Region
Status
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.
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.
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