Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- 2-year DFS rate
研究概览
简要总结
Exploring the efficacy of PD-1 inhibitor combination therapy strategies for adjuvant therapy in a population that has not achieved major pathological regression after neoadjuvant immunotherapy for non-small cell lung cancer: a multicenter, phase II clinical study
详细描述
This study explores the potential resistance problem in patients with low response rates after neoadjuvant ICIs treatment by addressing their potential resistance problems through an adjuvant immune combination regimen of ICIs, with the aim of providing a personalized choice of perioperative regimens for patients with early stage II-III resectable NSCLC, and to reduce the risk of postoperative recurrence and death in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects ≥ 18 years of age on the day of signed informed consent, male or female, and willing to follow study procedures;
- •ECOG score of 0 ~ 1;
- •Patients with resectable clinical stage II-IIIB (N2 only) NSCLC prior to neoadjuvant as assessed by the investigator (AJCC 8th ed.) and who are receiving 3 to 4 courses of standard PD-1 monoclonal antibody in combination with chemotherapy (platinum-containing two-agent chemotherapy) as neoadjuvant therapy during the neoadjuvant phase
- •Pathological evaluation of tumor for MPR (less than 10% residual tumor cells from the primary tumor) and specific remission rate (1 - residual tumor/primary tumor)
- •Subjects must have had complete resection of the NSCLC (no residual tumor and all surgical margins negative)
- •Histologically or cytologically confirmed squamous or non-squamous NSCLC.
排除标准
- •Subjects who have undergone segmental lung resection or wedge resection only, and subjects who have not undergone systemic or lobe-specific lymph node dissection;
- •Postoperative treatment with off-protocol antitumor therapy (e.g., radiotherapy, chemotherapy, targeted therapy, other immunotherapies, etc.; antitumor herbal therapies require a 2-week washout period);
- •Severe grade 3 or higher irAE or severe organ damage during neoadjuvant immunotherapy;
- •Previous history of allogeneic bone marrow or organ transplantation;
- •Previous or current interstitial pneumonitis/lung disease requiring systemic hormone therapy;
- •Uncontrolled hypertension (blood pressure ≥150/90 mmHg at rest), with antihypertensive medications maintained at a stable dose for 7 days prior to the first dose of study drug;
- •Combination of other malignant tumors within 5 years prior to the first dose of study drug that require active treatment, except for tumors cured in the opinion of the investigator;
研究组 & 干预措施
Sintilimab
干预措施: Sintilimab (Drug)
LM-108+Sintilimab
干预措施: LM-108+Sintilimab (Drug)
IBI310+Sintilimab
干预措施: IBI310+Sintilimab (Drug)
IBI363
干预措施: IBI363 (Drug)
结局指标
主要结局
2-year DFS rate
时间窗: 2 years
2-year DFS rate for Non-MPR treatment groups: DFS is defined as the time from surgery to tumor recurrence or death from any cause (whichever occurs first). 2-year DFS rate is defined as the probability of remaining free of disease recurrence or death at the 2-year time point.
次要结局
- 2-year OS rate(2 years)
- safety(2 years)
研究者
Chang Chen
Deputy Director of MD. PhD. Program in Thoracic Surgery, Secretary of the party committee of Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
Shanghai Pulmonary Hospital, Shanghai, China