Tislelizumab Combined With Thoracic Radiotherapy as Neoadjuvant Therapy for Resectable NSCLC: A Single Arm, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- pCR rate
研究概览
简要总结
This study aims to explore the efficacy and safety of radiotherapy combined with immunotherapy in the neoadjuvant treatment of resectable NSCLC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the study and voluntarily sign the informed consent form (ICF);
- •Aged 18-70 years, regardless of gender;
- •Previously untreated, histologically confirmed resectable stage IB-IIIA NSCLC (AJCC 9th edition staging);
- •At least one measurable lesion per RECIST v1.1 criteria;
- •Willing to provide PD-L1 immunohistochemistry slides and corresponding pathology reports for biomarker evaluation;
- •Presence of lesions suitable for radiotherapy as assessed by the study team;
- •ECOG performance status of 0-1;
- •Adequate organ function;
- •Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
- •Sufficient pulmonary function to tolerate planned lung resection surgery, as assessed by a surgeon;
- •Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. Both female participants of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of the study drug.
排除标准
- •Presence of locally advanced unresectable or metastatic disease;
- •NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;
- •Participants with known EGFR mutations or ALK translocations (non-squamous NSCLC subjects must have confirmed EGFR/ALK mutation status);
- •Prior systemic anticancer therapy for early-stage NSCLC, including investigational drugs; Contraindications to radiotherapy or inability to undergo radiotherapy;
- •History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease requiring steroid treatment;
- •Known active tuberculosis (TB) history; Known active infection requiring systemic therapy; Any known or suspected autoimmune disease or immunodeficiency;
- •Active hepatitis B infection; Administration of live vaccines within 30 days before the first dose;
- •Grade ≥2 peripheral neuropathy;
- •Prior treatment with PD-1/PD-L1 inhibitors or drugs targeting other T-cell receptors (e.g., CTLA-4, OX-40, etc.);
- •History of severe hypersensitivity to monoclonal antibodies;
- •Severe or uncontrolled underlying medical conditions;
- •Any condition that, in the investigator's judgment, may confound study results, interfere with the subject's participation, or compromise the subject's best interest in the study.
研究组 & 干预措施
Tislelizumab plus radiotherapy
Tislelizumab IV 200mg, d1, Q3W; concurrently combined with 40Gy/20f radiotherapy (3D-CRT/IMRT, IMRT, targeting only the lesion and positive lymph nodes), for 3-4 cycles.
干预措施: Tislelizumab (Drug)
Tislelizumab plus radiotherapy
Tislelizumab IV 200mg, d1, Q3W; concurrently combined with 40Gy/20f radiotherapy (3D-CRT/IMRT, IMRT, targeting only the lesion and positive lymph nodes), for 3-4 cycles.
干预措施: 3D-CRT/IMRT (Radiation)
结局指标
主要结局
pCR rate
时间窗: 18 months
Complete pathological response (pCR), defined as the proportion of patients in the ITT analysis set and surgical population analysis set who have no residual tumor in the resected primary tumor and metastatic lymph nodes as assessed by the investigator after the completion of neoadjuvant therapy. Patients who do not meet these criteria, including those who do not undergo surgical resection, will be considered non-responders.
次要结局
- MPR Rate(18 months)
- 1-year EFS Rate(Baseline up to 1 years)
研究者
Buhai Wang
Executive Vice-President
Northern Jiangsu People's Hospital