A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

Recruiting · NCT05211895 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

DomvanalimabDurvalumabPlacebo

What this trial is about

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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 ≥ 1% 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:
Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
Adequately treated carcinoma in situ, including Ta tumors 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
Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Active EBV infection, or known or suspected chronic active EBV infection at screening
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Where it is running

60 locations listed across 23 US states.

Research Site - Chandler, Arizona, United States
Research Site - Phoenix, Arizona, United States
Research Site - Fountain Valley, California, United States
Research Site - Santa Rosa, California, United States
Research Site - Washington D.C., District of Columbia, United States
Research Site - Jacksonville, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Saint Augustine, Florida, United States
Research Site - Macon, Georgia, United States
Research Site - Elmhurst, Illinois, United States
Research Site - Maywood, Illinois, United States
Research Site - Naperville, Illinois, United States
Research Site - Louisville, Kentucky, United States
Research Site - Baltimore, Maryland, United States
Research Site - Silver Spring, Maryland, United States
Research Site - Ann Arbor, Michigan, United States
Research Site - Detroit, Michigan, United States
Research Site - Minneapolis, Minnesota, United States
Research Site - Rochester, Minnesota, United States
Research Site - Reno, Nevada, United States
Research Site - East Brunswick, New Jersey, United States
Research Site - Florham Park, New Jersey, United States
Research Site - Buffalo, New York, United States
Research Site - Johnson City, New York, United States
Research Site - Asheville, North Carolina, United States
Research Site - Asheville, North Carolina, United States
Research Site - Charlotte, North Carolina, United States
Research Site - Winston-Salem, North Carolina, United States
Research Site - Columbus, Ohio, United States
Research Site - Columbus, Ohio, United States
Research Site - Maumee, Ohio, United States
Research Site - Oklahoma City, Oklahoma, United States
Research Site - Pittsburgh, Pennsylvania, United States
Research Site - Charleston, South Carolina, United States
Research Site - Chattanooga, Tennessee, United States
Research Site - Nashville, Tennessee, United States
Research Site - Nashville, Tennessee, United States
Research Site - Fort Sam Houston, Texas, United States
Research Site - Kingwood, Texas, United States
Research Site - Arlington, Virginia, United States
Research Site - Fort Belvoir, Virginia, United States
Research Site - Spokane Valley, Washington, United States
Research Site - Appleton, Wisconsin, United States
Research Site - Adapazarı, Turkey (Türkiye)
Research Site - Aguascalientes, Mexico
Research Site - Ahmedabad, India
Research Site - Aix-en-Provence, France
Research Site - Angers, France
Research Site - Ankara, Turkey (Türkiye)
Research Site - Ankara, Turkey (Türkiye)
Research Site - Antalya, Turkey (Türkiye)
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Bacolod, Philippines
Research Site - Bangalore, India
Research Site - Bangalore, India
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand

Showing 60 of 264 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →