Induction Therapy With Serplulimab Combined With Chemotherapy Followed by Local Therapy for Unresectable Stage III Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
For unresectable stage III (8th TNM) non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether induction chemoimmunotherapy followed by surgery or radiotherapy can provide good survival for this population. This prospective observational study aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery/radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient shall sign the Informed Consent Form.
- •Aged 18 ≥ years.
- •Histological or cytological diagnosis of unresectable NSCLC by needle biopsy, and stage III (8th TNM) confirmed by imageological examinations (CT, PET-CT or EBUS).
- •Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or
- •Life expectancy is at least 12 weeks.
- •At least 1 measurable lesion according to RECIST 1.
- •Patients with good function of other main organs (liver, kidney, blood system, etc.)
- •Patients with normal lung function can tolerate surgery;
- •Without systematic metastasis (including M1a, M1b and M1c);
- •Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
- •Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later).
排除标准
- •Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
- •Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
- •With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- •Participants who are allergic to the test drug or any auxiliary materials;
- •Participants with Interstitial lung disease currently;
- •Participants with active hepatitis B, hepatitis C or HIV;
- •Pregnant or lactating women;
- •Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
- •Participated in another therapeutic clinical study;
- •Other factors that researchers think it is not suitable for enrollment.
研究组 & 干预措施
Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC
干预措施: Chemoimmunotherapy (Drug)
Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC
干预措施: Surgery (Procedure)
Induction chemoimmunotherapy followed by surgery or radiotherapy for unresectable stage III NSCLC
干预措施: Radiation (Radiation)
结局指标
主要结局
Event-free survival (EFS)
时间窗: Up to 60 months
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don\'t undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
次要结局
- Objective response rate (ORR)(Up to 6 months)
- Major pathologic response (MPR)(Up to 6 months)
- Disease-free survival (DFS)(up to 60 months)
- Overall survival (OS)(up to 60 months)
- R0 rate(Up to 6 months)
- Severe adverse event (SAE) rate(up to 6 months)
- Health related quality of life (HRQol)(up to 6 months)
研究者
Peng Zhang
Professor
Shanghai Pulmonary Hospital, Shanghai, China