NCT03996473

Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases

An Open-label, Multicenter, Phase 1/2 Study of Radium-223 Dichloride in Combination With Pembrolizumab in Participants With Stage IV Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Radium-223 dichloride (Xofigo, BAY 88-8223)	55 kBq/kg, intravenous (IV) injection, every 6 weeks for up to 6 administrations
DRUG	Pembrolizumab	200 mg, IV infusion, every 3 weeks for a maximum of up to 35 administrations

Timeline

• Start date: 2020-03-06
• Primary completion: 2021-04-14
• Completion: 2023-01-30
• First posted: 2019-06-24
• Last updated: 2024-10-10
• Results posted: 2024-10-10

Locations

6 sites across 4 countries: United States, Belgium, Netherlands, Spain

Regulatory

• FDA-regulated drug study