A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy
Summary
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.
Arms & interventions
- DrugDurvalumab
Durvalumab IV (Intravenous infusion)
- DrugDomvanalimab
Domvanalimab IV (Intravenous infusion)
- OtherPlacebo
Placebo IV (Intravenous infusion)
Outcome measures
Primary
Progression Free Survival (PFS)
Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%.
Time frame: Up to 8 years after randomization
Secondary
Progression Free Survival (PFS)
Time frame: Up to 8 years after randomization
Overall Survival (OS)
Time frame: Approximately 8 years after randomization
Objective Response Rate (ORR)
Time frame: Approximately 8 years after randomization
Duration of Response (DoR)
Time frame: Approximately 8 years after randomization
Time from randomization to second progression (PFS2)
Time frame: Approximately 8 years after randomization
Time from randomization to first date of distant metastasis or death (TTDM)
Time frame: Approximately 8 years after randomization
Time to first subsequent therapy (TFST)
Time frame: Approximately 8 years after randomization
Concentration of Durvalumab and Domvanalimab
Time frame: Approximately 12 weeks after last IP dose
PFS6, PFS12, PFS18, PFS24
Time frame: Approximately 6, 12, 18 and 24 months after randomization
Anti-Drug Antibodies (ADAs)
Time frame: Approximately 12 weeks after last IP dose.
Time to deterioration in pulmonary symptoms (TTFCD)
Time frame: Approximately 8 years after randomization
PFS investigator
Time frame: Up to 8 years after randomization
OS 24
Time frame: Approximately 24 months after randomization
Eligibility criteria
Study locations (43)
Research Site
Chandler, Arizona, 85224
Research Site
Phoenix, Arizona, 85054
Research Site
Fountain Valley, California, 92708
Research Site
Santa Rosa, California, 95403
Research Site
Washington D.C., District of Columbia, 20016
Research Site
Jacksonville, Florida, 32224
Research Site
Orlando, Florida, 32804
Research Site
Saint Augustine, Florida, 32086
Research Site
Macon, Georgia, 31217
Research Site
Elmhurst, Illinois, 60126
Research Site
Maywood, Illinois, 60153
Research Site
Naperville, Illinois, 60540
Research Site
Louisville, Kentucky, 40202
Research Site
Baltimore, Maryland, 21224
Research Site
Silver Spring, Maryland, 20910
Research Site
Ann Arbor, Michigan, 48106-0995
Research Site
Detroit, Michigan, 48202
Research Site
Minneapolis, Minnesota, 55407
Research Site
Rochester, Minnesota, 55905
Research Site
Reno, Nevada, 89511
Research Site
East Brunswick, New Jersey, 08816
Research Site
Florham Park, New Jersey, 07932
Research Site
Buffalo, New York, 14221
Research Site
Johnson City, New York, 13790
Research Site
Asheville, North Carolina, 28805
Research Site
Asheville, North Carolina, 28806
Research Site
Charlotte, North Carolina, 28204
Research Site
Winston-Salem, North Carolina, 27157
Research Site
Columbus, Ohio, 43214
Research Site
Columbus, Ohio, 43219
Research Site
Maumee, Ohio, 43537
Research Site
Oklahoma City, Oklahoma, 73102
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Charleston, South Carolina, 29401
Research Site
Chattanooga, Tennessee, 37404
Research Site
Nashville, Tennessee, 37203
Research Site
Nashville, Tennessee, 37232
Research Site
Fort Sam Houston, Texas, 78234
Research Site
Kingwood, Texas, 77339
Research Site
Arlington, Virginia, 22205
Research Site
Fort Belvoir, Virginia, 22060
Research Site
Spokane Valley, Washington, 99216
Research Site
Appleton, Wisconsin, 54911