An Open-Label, Single-Arm Study Evaluating the Safety and Efficacy of NK010 Cell Injection Combined With PD-1 Antibody and Platinum-Based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This open-label, single-arm study is designed to evaluate the safety and preliminary efficacy of NK010 cell injection combined with a PD-1 antibody and platinum-based chemotherapy as neoadjuvant therapy in patients with resectable non-small cell lung cancer (NSCLC). The study aims to assess the safety profile, feasibility of administration, and potential antitumor activity of this combination regimen.
详细描述
Participants with histologically or cytologically confirmed, resectable non-small cell lung cancer (NSCLC) will receive a neoadjuvant regimen consisting of NK010 cell injection, an anti-PD-1 antibody, and standard platinum-based doublet chemotherapy.
The primary objective of this study is to assess the safety and feasibility of this combination regimen in the preoperative setting. Secondary objectives include the exploration of potential antitumor activity. The study utilizes a sequential dose-escalation design, with NK010 administered at three planned dose levels.
Following neoadjuvant therapy and surgical resection, postoperative adjuvant therapy will be administered at the investigator's discretion in accordance with standard clinical practice.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and voluntarily sign the written informed consent form (ICF).
- •Male or female patients aged ≥18 years.
- •Histologically and/or cytologically confirmed resectable stage IB to IIIA non-small cell lung cancer (NSCLC) according to AJCC 8th edition.
- •Treatment-naïve NSCLC (no prior systemic anticancer therapy).
- •No sensitizing EGFR mutations (exon 19 deletion, exon 21 L858R) and no ALK gene rearrangement.
- •At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Estimated life expectancy of more than 6 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Adequate bone marrow, liver, and renal function.
- •Female participants of childbearing potential must have a negative pregnancy test prior to initiation of study treatment.
排除标准
- •Prior receipt of any systemic anticancer therapy.
- •Known sensitizing EGFR mutations or ALK gene rearrangements.
- •Active, known, or suspected autoimmune disease.
- •Interstitial lung disease.
- •Any medical condition, therapy, or laboratory abnormality that, in the opinion of the investigator, could confound the study results, interfere with the participant's ability to comply with study procedures, or is not in the best interest of the participant.
- •Locally advanced unresectable or metastatic NSCLC.
- •Major cardiovascular events, unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.
- •Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use effective contraception during the study.
- •Any other condition judged by the investigator to make the participant unsuitable for clinical trial participation.
研究组 & 干预措施
NK010 + PD-1 Antibody + Platinum-Based Chemotherapy
Participants will receive neoadjuvant therapy for a total of 3 cycles, with each cycle lasting 3 weeks. NK010 cell injection will be administered in combination with a PD-1 antibody and platinum-based chemotherapy. After completing 3 cycles of treatment, participants will undergo surgical resection, followed by pathological assessment to evaluate outcomes such as major pathological response (MPR), pathological complete response (pCR), and R0 resection rate. NK010 administration will be evaluated at three planned dose levels.
干预措施: PD-1 antibody (Drug)
NK010 + PD-1 Antibody + Platinum-Based Chemotherapy
Participants will receive neoadjuvant therapy for a total of 3 cycles, with each cycle lasting 3 weeks. NK010 cell injection will be administered in combination with a PD-1 antibody and platinum-based chemotherapy. After completing 3 cycles of treatment, participants will undergo surgical resection, followed by pathological assessment to evaluate outcomes such as major pathological response (MPR), pathological complete response (pCR), and R0 resection rate. NK010 administration will be evaluated at three planned dose levels.
干预措施: NK010 (Biological)
结局指标
主要结局
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 1 year after first dose of NK010
Number of subjects experiencing adverse events, and the frequency and severity of adverse events. The type, frequency, onset, and severity of treatment-emergent adverse events (TEAEs) will be assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Dose Limiting Toxicities (DLTs)
时间窗: Up to 21 days after first dose of NK010
Identification of DLTs to determine the maximum tolerated dose (MTD).
次要结局
- Major pathological response (MPR)(Within 6 weeks after completion of neoadjuvant therapy)
- Pathological complete response (pCR)(Within 6 weeks after completion of neoadjuvant therapy)
- R0 Resection Rate(Within 6 weeks after completion of neoadjuvant therapy)
- Objective Response Rate (ORR)(Up to preoperative assessment (approximately 12 weeks from treatment initiation))
研究者
Jianxing He
President, Guangzhou Institute of Respiratory Health
The First Affiliated Hospital of Guangzhou Medical University