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 - Study of radium-223 dichloride in combination w/ pembrolizumab

Bayer Consumer Care AG0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月15日

研究概览

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•- 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
•- 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

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