2023-504434-22-00招募中3 期
A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment (HARMONi)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 23
- 主要终点
- OS in the mITT population
研究概览
简要总结
- To compare overall survival (OS) in the Modified Intent-to-Treat (mITT) population between AK112 combined with pemetrexed and carboplatin and placebo combined with pemetrexed and carboplatin, in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations who have progressed on or following EGFR tyrosine kinase inhibitor (TKI) therapy.
- To compare progression-free survival (PFS) assessed by the Independent Radiology Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, in the mITT population between AK112 combined with pemetrexed and carboplatin and placebo combined with pemetrexed and carboplatin, in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutations who have progressed on or following EGFR TKI therapy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Maintenance Period
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- •Life expectancy ≥ 3 months
- •Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy
- •The tumor histology, cytology or blood test confirmed the presence of EGFR activating mutations before enrollment
- •Have previously received EGFR-TKI treatment and the treatment has failed
- •Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1
- •Major organ function prior to treatment meets the criteria defined in Protocol
- •Patients of childbearing potential must agree to use highly effective contraceptive measures
排除标准
- •Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma
- •Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment
- •There is a history of major diseases 1 year prior to the first dose
- •Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
- •Received chest radiation therapy prior to the first dose
- •Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- •Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- •There are reports confirming the existence of other driver gene mutations with known drug treatments
- •Subjects who received any prior treatments targeting the mechanism of tumor immunity
- •The subject has received systemic anti-tumor therapy other than EGFR-TKI
- •Currently enrolled in any other clinical study
- •Received EGFR-TKI treatment, palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose
- •Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels
- •Symptomatic central nervous system metastases
- •Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
研究组 & 干预措施
ivonescimab
Experimental
Participants receiving ivonescimab
干预措施: ivonescimab (Drug)
结局指标
主要结局
OS in the mITT population
OS in the mITT population
PFS assessed by IRRC based on RECIST v1.1 in the mITT population
PFS assessed by IRRC based on RECIST v1.1 in the mITT population
次要结局
- ORR (including DoR) assessed by IRRC based on RECIST v1.1 in the mITT Population
- Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results
- PK characteristics: AK112 serum drug concentration at different time points after AK112 administration
- Immunogenicity assessment: number and percentage of patients with detectable anti-AK112 antibody (ADA).
研究者
Medical Information
Scientific
Summit Therapeutics Inc.
研究点 (23)
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