Stopped: LPLV reached on 30Jan2023. Study was closed early for feasibility reasons related to enrollment of first line IO naïve patients. Safety data is consistent with the known safety profile of both drugs and no new safety issues have been observed
The purpose of the study was to determine the safety and test the efficacy of the combination of radium-223 dichloride and pembrolizumab in patients with stage IV non-small cell lung cancer (NSCLC) with bone metastases who either had not received any systemic therapy for their advanced disease or had progressed on prior immunologic checkpoint blockade with antibodies against the programmed cell death protein-(ligand) 1 (PD-1/PD-L1). In this study researchers wanted to measure tumor shrinkage in response to treatment and how long that shrinkage lasted and gathered information on safety. Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against the tumor. Radium-223 dichloride is an alpha particle-emitting radioactive agent which kills cancer cells.
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Number of Participants With Treatment-emergent Adverse Events in Phase 1
Timeframe: Up to 218 days
Number of Participants With Treatment-emergent Serious Adverse Events in Phase 1
Timeframe: Up to 278 days
Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1
Timeframe: Within 6 weeks after the first administration of pembrolizumab
Objective Response Rate (ORR) Per RECIST v1.1 in Phase 2
Timeframe: 0 day as Phase 2 never started due to the early termination of the study