NCT06299371尚未招募2 期
A Prospective, Single-arm Study of Adebrelimab in Combination With Paclitaxel for Injection (Albumin Bound) and Platinum Chemotherapy as Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) Harboring Driver Gene Mutations
Liaoning Tumor Hospital & Institute0 个研究点目标入组 36 人开始时间: 2024年4月15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
- 36
- 主要终点
- Pathological complete response rate
研究概览
简要总结
This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations
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
- •Male or female aged ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •Resectable non-small cell lung cancer harboring driver gene mutations.
- •At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.
- •Have adequate organ function.
- •Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication；Females should not be breastfeeding；Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception.
- •Voluntarily comply with the treatment protocol.
排除标准
- •Previously treated with any anti-tumor therapy;
- •Subject with known autoimmune disease
- •Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known active hepatitis B or C.
- •Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites).
- •Subject with severe liver and kidney dysfunction.
- •Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapy for systematic treatment within 14 days before the first administration of the study
- •Subject with previous malignancies within 5 years, except for cured in situ cancer.
- •Subject with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to lung function.
- •Subject with uncontrolled hypertension.
- •Prior organ transplantation including allogenic stem-cell transplantation.
- •Known hypersensitivity to the study drug or any of its excipients.
- •Other situations that the investigator considers unsuitable for the enrollment.
研究组 & 干预措施
neoadjuvant immuno-chemotherapy
Experimental
Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy
干预措施: Adebrelimab (Drug)
neoadjuvant immuno-chemotherapy
Experimental
Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy
干预措施: paclitaxel for injection (albumin bound) (Drug)
neoadjuvant immuno-chemotherapy
Experimental
Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy
干预措施: Cisplatin or Carboplatin (Drug)
结局指标
主要结局
Pathological complete response rate
时间窗: at 12 months
pCR rate, the proportion of patients achieved pathologic complete response (lung and lymph node without tumor residual assessed by pathology review)
次要结局
- R0 rate(12 months)
- Major pathologic response rate(12 months)
- Event Free Survival(up to 5 years)
- Overall Survival(up to 5 years)
- Objective response rate(12 months)
- Adverse Events(up to 5 years)
研究者
Hongxu Liu
Chief Physician
Liaoning Tumor Hospital & Institute
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