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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

NCT03996473 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-10-10

Study results available
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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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2021-04-14
Completion
2023-01-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Netherlands
  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03996473 on ClinicalTrials.gov