Study on the Efficacy and Safety of KN046 Combined With Acitinib as a Neoadjuvant Therapy in Resectable Stage IB-IIIB Non-small Cell Lung Cancer (NSCLC) Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- MPR
研究概览
简要总结
Evaluation of the efficacy of KN046 combined with acitinib as a neoadjuvant therapy for resectable NSCLC through primary pathological response rate and surgical resection rate
详细描述
The purpose of this study is to evaluate the rate of major pathological remission (MPR) with preoperative use of KN046 versus axitinib, and thus to assess the efficacy of KN046 in combination with axitinib in patients with Stage IB-IIIB (Stage IIIB only T3N2M0) NSCLC (according to the 8th edition of the AJCC classification) who are scheduled to undergo surgery. Eligible subjects for this study were candidates for surgery for resectable stage IB-IIIB (stage IIIB only T3N2M0) NSCLC as judged by the investigator, with no evidence of distant metastases as assessed, and no evidence of unresectable local regional tumour extension.
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
- •The subject is at least 18 years old and<75 years old on the day of signing the informed consent form, regardless of gender, and is willing to follow the research procedure;
- •Confirmed by histology or cytology as non-small cell lung cancer;
- •NSCLC patients evaluated by researchers as resectable in stage IB-IIIB (stage IIIB only limited to T3N2M0) (AJCC 8th edition);
- •Has not received any anti-tumor treatment in the past, including but not limited to systemic chemotherapy, immunotherapy, or radiotherapy;
- •No allergenic EGFR mutation or ALK change;
- •The ECOG score is 0-1 points.
排除标准
- •The lesion of squamous non-small cell lung cancer presents as a central type of lung cancer accompanied by cavity formation or invasion of blood vessels, with a high risk of hemoptysis;
- •Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy;
- •Previous history of allogeneic bone marrow or organ transplantation;
- •Subjects who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular pathway replacement surgery) or have not recovered from surgical treatment within 28 days before the administration of this trial;
- •Prior to allocation, they have received systemic anti-cancer treatment, including research drugs targeting current malignant tumors;
- •Other known malignant tumors are progressing or require active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in situ) who have received possible radical treatment are not excluded;
- •Pregnant and/or lactating women.
研究组 & 干预措施
Treatment group
KN046 combined with axitinib as a neoadjuvant treatment regimen
干预措施: KN046 plus Axitinib (Drug)
结局指标
主要结局
MPR
时间窗: one month within postsurgery
MPR is defined as the presence of ≤ 10% of active tumor cells in postoperative pathology (primary lesion).
Surgical resection rate
时间窗: six weeks after last cycle of neoadjuvant therapy
Surgical resection rate: refers to the proportion of subjects who completed the surgery according to the plan, defined as the distance from the last neoadjuvant treatment administration, and the surgical time ≤ 6 weeks.
次要结局
- Complication rate(three months within postsurgery)
- pCR(one month within postsurgery)
- ORR(one month within postsurgery)
研究者
Chang Chen
Professor
Shanghai Pulmonary Hospital, Shanghai, China