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
- Conditions
- niet-kleincellige longkankerNon-small cell lung cancerRadium-223
- Registration Number
- NL-OMON49669
- Lead Sponsor
- Bayer Consumer Care AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
- Histologically or cytologically confirmed diagnosis of stage IV NSCLC. Phase
2 Cohort 1: no Epidermal Growth Factor Receptor (EGFR) sensitization
(activating) mutation or anaplastic lymphoma kinase (ALK)/ROS1 rearrangement.
Treatment naïve (no prior systemic therapy) for their metastatic NSCLC. Phase 2
Cohort 2: progression on prior treatment with an immune checkpoint inhibitor.
Phase 1 includes participants meeting either Cohort 1 or Cohort 2 criteria.
- Measurable disease per RECIST v1.1.
- At least 2 skeletal metastases.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Adequate bone marrow and organ function.
Other criteria
- Participants must be on a BHA treatment, such as bisphosphonates or denosumab
treatment unless such treatment is contraindicated or not recommended per
investigator*s judgement and inclusion is agreed to by the medical monitor.
- Previous or concurrent cancer within 3 years prior to enrollment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
or with an agent directed to another stimulatory or co-inhibitory T-cell
receptor. Phase 2 Cohort 2: was discontinued from that treatment due to a Grade
3 or higher immune-related AEs (irAEs).
- Known active central nervous system metastases and/or carcinomatous
meningitis. Participants with previously treated brain metastases may
participate provided they are radiologically stable, clinically stable, and
without requirement of steroid treatment for at least 14 days prior to first
dose of study treatment.
- Active autoimmune disease that has required systemic treatment in the past 2
years.
- History of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.
- Known history or presence of osteonecrosis of jaw.
- Ongoing infection >Grade 2 NCI-CTCAE v.5.0 requiring systemic therapy.
- Significant acute GI disorders with diarrhea as a major symptom e.g., Crohn*s
disease, malabsorption, or * NCI-CTCAE v.5.0 Grade 2 diarrhea of any etiology.
- Prior treatment with radium-223 dichloride or any therapeutic
radiopharmaceutical.
- Prior radiotherapy within 21 days of planned start of study treatment.
- History of osteoporotic fracture
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase 1<br /><br>* Adverse events (AE) assessments using National Cancer Institute (NCI) Common<br /><br>Terminology Criteria for Adverse Events (CTCAE) (v.5.0) and Incidence of dose<br /><br>limiting toxicities (DLTs)<br /><br><br /><br>Phase 2<br /><br>* ORR per RECIST v1.1</p><br>
- Secondary Outcome Measures
Name Time Method <p>Phase 1<br /><br>* Objective response rate (ORR) per Response Evaluation Criteria in Solid<br /><br>Tumors (RECIST) v1.1 and iRECIST<br /><br>* Duration of response (DOR) per RECIST v1.1 and iRECIST<br /><br>* Disease control rate (DCR) per RECIST v1.1 and iRECIST<br /><br><br /><br>Phase 2<br /><br>* ORR per iRECIST<br /><br>* DOR per RECIST v1.1 and iRECIST<br /><br>* DCR per RECIST v1.1 and iRECIST<br /><br>* Progression free survival (PFS) per RECIST v1.1 and iRECIST<br /><br>* OS<br /><br>* AE assessments using NCI CTCAE (v.5.0)</p><br>