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
TerminatedPhase 1Results postedLast updated 10 October 2024
What this trial tests
Phase 1 trial testing Radium-223 dichloride (Xofigo, BAY 88-8223) in Carcinoma, Non-Small-Cell Lung in 8 participants. Terminated before completion.
18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events in Phase 1Primary· Up to 218 days
A treatment-emergent adverse event (TEAE) was any untoward medical occurrence in a participant, whether or not related to the treatment, arising or worsening after start of study treatment administration until the end of treatment visit (EoT visit, i.e. 30 \[+7\] days after last dose of study treatment). Severities of the TEAEs are summarized overall and by the maximum grade experienced by the participants for any TEAEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.0.
Any TEAE
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
7
Any TEAE - Maximum Grade 1
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
0
Any TEAE - Maximum Grade 2
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
3
Any TEAE - Maximum Grade 3
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
2
Any TEAE - Maximum Grade 4
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
0
Any TEAE - Maximum Grade 5
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
2
Number of Participants With Treatment-emergent Serious Adverse Events in Phase 1Primary· Up to 278 days
A treatment-emergent serious adverse event (TESAE) was any untoward medical occurrence that resulting in death, initial or prolonged inpatient hospitalization, life-threatening, persistent disability/incapacity, congenital anomaly/birth defect, another medical important serious event as judged by the investigator arising or worsening after start of study treatment administration until 90 days after the cessation of study treatment for serious AE (regardless of causality) or until the end of treatment visit (EoT visit, i.e. 30 \[+7\] days after last dose of study treatment) visit if the partici
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
2
Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1Primary· Within 6 weeks after the first administration of pembrolizumab
Any of following toxicities (exceptions as in protocol) during DLT window was considered a DLT if assessed by investigator to be possibly, probably or definitely related to study treatment: 1.Grade 4 non-hematologic toxicity. 2.Grade 4 hematologic toxicity ≥7 days. 3.Any non-hematologic AE (excl. lab) ≥Grade 3. 4.Any Grade 3 non-hematologic lab value if clinically significant medical intervention required, or the abnormality led to hospitalization, or the abnormality persisted for \>1 week. 5.Grade 3 abnormality in AST, ALT, or bilirubin without liver metastases at screening; The abnormality r
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
0
Number of Participants Categorized by Best Tumor Responses Per RECIST v1.1 in Phase 1Secondary· Up to 188 days
The tumor responses were evaluated per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST V1.1).
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
1
Radium-223 Dichloride + Pembrolizumab
5
Radium-223 Dichloride + Pembrolizumab
1
Objective Response Rate (ORR) Per RECIST v1.1 in Phase 1Secondary· Up to 188 days
ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) during the course of the study. It was evaluated per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST V1.1). Complete Response (CR): Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \< 10mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baselin
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
0
Disease Control Rate (DCR) Per RECIST v1.1 in Phase 1Secondary· Up to 188 days
DCR was defined as the percentage of participants with CR or PR, or SD for at least 6 weeks during the course of the study. It was evaluated per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST V1.1). Complete Response (CR): Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to \< 10mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of
Group
Value
95% CI
Radium-223 Dichloride + Pembrolizumab
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of study treatment to 90 days after cessation of study treatment or 30 days after last dose of study treatment (EoT visit) if subject started new anti-cancer therapy (whichever was earlier) for serious TEAEs; or until EoT visit for other TEAEs, with a maximum of 278 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 10 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03996473.