NCT07158840尚未招募2 期
A Single Arm, Multi-center, Phase II Study of AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC) Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment
Akeso1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
研究概览
简要总结
AK112 in non-squamous non-small cell lung cancer patients with actionable genomic alterations (AGA) who have failed to previous tyrosine kinase inhibitor (TKI) treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the Informed Consent Form (ICF) voluntarily。
- •Participants must be aged between 18 and 75 years (inclusive), regardless of gender.
- •ECOG performance status of 0 or
- •With a life expectancy of ≥3 months.
- •Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC.
- •Prior to enrollment, participants must have at least one actionable genomic alteration (AGA) confirmed by tumor histology, cytology, or blood-based testing, including: EGFR, ALK, ROS1, NTRK, RET, BRAF and MET. Participants must provide a prior AGA test report; otherwise, AGA testing must be performed at the study site or at a site-designated laboratory before enrollment.
- •Previous treatment failure with an AGA-targeted TKI.
- •At least one measurable extracranial lesion as defined by RECIST v1.
- •Adequate organ function confirmed.
排除标准
- •Histological or cytological pathology confirming the presence of a small-cell carcinoma component or a predominant squamous cell carcinoma component.
- •AGA test report showing the presence of a common EGFR sensitizing mutation.
- •Prior receipt of immunotherapy.
- •Prior receipt of any systemic anti-tumor therapy for advanced-stage (IIIB-IV) NSCLC other than AGA-targeted TKIs.
- •Concurrent participation in another clinical study, unless it is a non-interventional study or the follow-up phase of an interventional study.
- •Receipt of AGA-targeted TKI therapy within 2 weeks prior to the first dose; receipt of non-specific immunomodulatory therapy within 2 weeks prior to the first dose.
- •Imaging during the screening period shows tumor encasement of major blood vessels or significant necrosis/cavitation, and the investigator determines that study participation would pose a bleeding risk.
- •Imaging during the screening period shows tumor invasion of surrounding vital organs or blood vessels.
- •Central nervous system metastases: participants assessed by the investigator as not requiring local treatment may be eligible; leptomeningeal metastases are not eligible.
- •History of malignancy other than NSCLC within 3 years prior to the first dose; participants with other malignancies that have been cured by local treatment are allowed.
- •Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
- •History of major medical conditions within 1 year prior to the first dose.
研究组 & 干预措施
Experimental Arm
Experimental
干预措施: AK112 (Drug)
结局指标
主要结局
Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
时间窗: up to 2 years
Proportion of subjects who have a complete or partial response as assessed according to RECIST v1.1.
次要结局
- Overall survival (OS)(up to 2 years)
- Progression-free survival (PFS)(up to 2 years)
- Duration of response (DoR)(up to 2 years)
- Disease control rate (DCR)(up to 2 years)
- Time to response (TTR)(up to 2 years)
- Percentage of participants with adverse event (AE)(From the subject signs the Informed Consent Form to 30 days (AE) and 90 days (Serious AE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first,up to 2 years)
- Observed concentrations of AK112(From date of enrollment until the end of treatment, assessed up to 2 years)
- Number of participants who develop detectable anti-drug antibodies (ADAs)(From first dose of AK112 through 90 days after last dose of AK112,up to 2 years)
- Number of participants with programmed cell death ligand 1 (PD-L1) expression positive who achieve CR/PR(From date of enrollment until the end of treatment, assessed up to 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLCLung Cancer, Non-Small CellNCT06769295Sichuan University28
进行中（未招募）
2 期
A Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLCNSCLCNCT04736823Akeso265
进行中（未招募）
2 期
评估 AK112 治疗 AGA 相关 TKI 耐药的非鳞状非小细胞肺癌的 II 期临床研究CTR2025326860
已完成
1 期
A Trial of AK112 (PD-1/VEGF Bispecific Antibody) in Patients With NSCLCNon-small Cell Lung CancerNCT04900363Akeso108
Unknown
2 期
GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA TrialNon Small Cell Lung CancerNCT02319577IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy80