Neoadjuvant Tislelizumab and Platinum-Based Doublet Chemotherapy in Stage II-IIIB EGFR-Mutated Lung Adenocarcinoma With PD-L1 Positive Expression -- A Phase II Study (DuoVitality)"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Major pathologic response rate (MPR) （proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes）
研究概览
简要总结
Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.
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
- •Volunteer to participate in clinical research;Fully understand and be Informed of the study and sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures;
- •Age 18-75 (boundary value included), no gender limitation;
- •Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American Joint Commission on Cancer, 8th Edition);
- •EGFR gene mutation positive (can be tested by tissue or blood samples);
- •ECOG PS score 0-1 (including boundary value);
- •Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed;
- •Meet the conditions for receiving platinum containing two-drug chemotherapy;
- •The expected survival time is ≥3 months, and feasible surgery is planned;
排除标准
- •Any previous treatment for current lung cancer, including systemic therapy or radiotherapy;
- •there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV).
- •A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.Patients with any severe and/or uncontrolled disease or symptom
研究组 & 干预措施
Neoadjuvant ICI combined with chemotherory
intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
干预措施: Tislelizumab (Drug)
Neoadjuvant ICI combined with chemotherory
intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
干预措施: pemetrexed (Drug)
Neoadjuvant ICI combined with chemotherory
intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
干预措施: cis-platemum (Drug)
Neoadjuvant ICI combined with chemotherory
intravenous injection :Tislelizumab + pemetrexed + platinum Q3W 2-4 cycles
干预措施: or carboplatin (Drug)
结局指标
主要结局
Major pathologic response rate (MPR) （proportion of patients with no more than 10% remaining live tumor cells in the resected primary tumor and in all resected lymph nodes）
时间窗: 15-18 weeks after enrollment
MPR of surgical specimens from patients who were operable after neoadjuvant therapy was evaluated
次要结局
- ORR: Proportion of patients who achieved complete response (CR) or partial response (PR) among all randomized patients with measurable disease at baseline assessed according to RECIST version 1.1(6-12weeks after enrollment)
- pCR: proportion of patients with no residual tumor in resected primary tumor and lymph nodes(15-18 weeks after enrollment)
- Descending rate of lymph nodes(15-18 weeks after enrollment)
- Number of Participants with Adverse Events(through study completion, an average of 35weeks)
- The time of surgery delay(4-6weeks after completation of the last neoadjuvant therapy)
- minimally invasive surgery rate(4-6weeks after completation of the last neoadjuvant therapy)
研究者
Jun Liu
Chief Physician
Guangzhou Institute of Respiratory Disease