NCT05052801已完成3 期
A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 547
- 试验地点
- 496
- 主要终点
- Overall Survival
研究概览
简要总结
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy
- •Fibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy
- •Eastern Cooperative Oncology Group (ECOG) less than or equal to 1
- •Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1
- •Participant has no contraindications to mFOLFOX6 chemotherapy
- •Adequate organ and bone marrow function:
- •absolute neutrophil count greater than or equal to 1.5 times 10^9/L
- •platelet count greater than or equal to 100 times 10^9/L
- •hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
- •aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)
- •calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)
- •international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
排除标准
- •Prior treatment for metastatic or unresectable disease (Note: prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed if completed more than 6 months prior to first dose of study treatment)
- •Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway
- •Known human epidermal growth factor receptor 2 (HER2) positive
- •Untreated or symptomatic central nervous system (CNS) disease or brain metastases
- •Peripheral sensory neuropathy greater than or equal to Grade 2
- •Clinically significant cardiac disease
- •Other malignancy within the last 2 years (exceptions for definitively treated disease)
- •Chronic or systemic ophthalmological disorders
- •Major surgery or other investigational study within 28 days prior to first dose of study treatment
- •Palliative radiotherapy within 14 days prior to the first dose of study treatment
- •Evidence of or recent history (within 6 months) of corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
研究组 & 干预措施
Bemarituzumab with mFOLFOX6
Experimental
干预措施: mFOLFOX6 (Drug)
Placebo with mFOLFOX6
Active Comparator
干预措施: Placebo (Drug)
Bemarituzumab with mFOLFOX6
Experimental
干预措施: Bemarituzumab (Drug)
Placebo with mFOLFOX6
Active Comparator
干预措施: mFOLFOX6 (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to approximately 3.5 years
Overall survival in FGFR2b ≥ 10% 2+/3+ tumor cell staining participants
次要结局
- Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)(Up to approximately 3.5 years)
- Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)(Baseline up to approximately 3.5 years)
- Stomach Cancer Related Symptom Mean Subjective Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)(Up to approximately 3.5 years)
- Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)(Up to approximately 3.5 years)
- Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma(Day 1 up to approximately 3.5 years)
- Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma(Day 1 up to approximately 3.5 years)
- Disease Control Rate(Up to approximately 3.5 years)
- Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)(Up to approximately 3.5 years)
- Overall Survival(Up to approximately 3.5 years)
- Duration of Response (DOR)(Up to approximately 3.5 years)
- Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)(Baseline up to approximately 3.5 years)
- Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)(Day 1 up to approximately 3.5 years)
- Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)(Baseline up to approximately 3.5 years)
- Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22)(Up to approximately 3.5 years)
- Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score(Up to approximately 3.5 years)
- Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score(Up to approximately 3.5 years)
- Number of Participants with an Anti-bemarituzumab Antibody Formation(Day 1 up to approximately 3.5 years)
- Progression-free Survival (PFS)(Up to approximately 3.5 years)
- Objective Response Rate (ORR)(Up to approximately 3.5 years)
研究者
研究点 (496)
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