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

Bayer Consumer Care AG0 个研究点目标入组 154 人开始时间: 2020年3月3日最近更新: 2020年9月7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.
•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 46

•- 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

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