NCT07309952尚未招募2 期
Neoadjuvant Stereotactic Body Radiotherapy Followed by Sintilimab Plus Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer With Contralateral Mediastinal (N3) Lymph Node Metastasis: A Prospective Phase II Clinical Trial
Yang Hong0 个研究点目标入组 28 人开始时间: 2025年12月31日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- Contralateral Mediastinal Lymph Node Downstaging Rate
研究概览
简要总结
This is a Phase II clinical trial evaluating the efficacy and safety of a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) that has spread to lymph nodes on the opposite side of the chest (known as N3 lymph node involvement).
The study will enroll 28 patients aged 18 to 75 years with previously untreated, potentially resectable NSCLC classified as stage IIIB-IIIC. Participants will receive a combination of stereotactic body radiation therapy (SBRT) to the primary lung tumor, followed by two cycles of sintilimab (an immunotherapy drug) plus platinum-based chemotherapy before surgery.
The main goals of the study are to see whether this treatment can shrink or eliminate cancer in the contralateral mediastinal lymph node (lymph node downstaging) and allow more patients to undergo curative surgery. Secondary goals include assessing pathological response rates, surgical outcomes, survival, and safety.
Patients will be closely monitored during and after treatment, with follow-up visits planned for up to 5 years after surgery.
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
- •Voluntary Participation: The patient volunteers to participate and signs a written informed consent form.
- •Pathology and Staging: Cytologically or histologically confirmed, previously untreated non-small cell lung cancer (NSCLC) with contralateral mediastinal lymph node involvement (N3), classified as stage IIIB or IIIC according to the 9th edition of the International Association for the Study of Lung Cancer (IASLC) staging manual. Baseline staging must be performed with either PET/CT or a combination of contrast-enhanced CT of chest/abdomen + bone scan + brain MRI.
- •Surgical Feasibility: The lung lesion is considered **potentially resectable as evaluated by a multidisciplinary team that includes a thoracic surgeon.
- •Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Adequate Organ Function:
- •(1) Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (2) Platelet count ≥ 100 x 10^9/L (3) Hemoglobin > 9.0 g/dL (4) Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥ 40 mL/min (5) Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 3 x ULN (6) Total bilirubin ≤ 1.5 x ULN (7) Forced expiratory volume in 1 second (FEV1) ≥ 1.2 L or > 40% of predicted value (8) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) within normal limits.
- •6. Age: Between 18 and 75 years old.
- •Exclusion Criteria
- •Autoimmune Disease: Active or suspected autoimmune disease. Exception: Patients with vitiligo, type I diabetes mellitus, or hypothyroidism requiring only hormone replacement therapy (e.g., Hashimoto's thyroiditis) with no signs of active disease may be enrolled.
- •Immunosuppressive Therapy: Requires systemic corticosteroid therapy (>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to enrollment.
- •Prior Chest Radiotherapy: History of prior radiotherapy to the chest.
- •Active Bleeding: Presence of clinically significant active bleeding prior to treatment.
- •Severe Organ Dysfunction: Severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system disease, or cachexia, as judged by the investigator to be intolerable to chemo-radiotherapy.
- •Poorly Controlled Diabetes: History of diabetes mellitus for >10 years with unsatisfactory glycemic control.
- •Interstitial Lung Disease: History of interstitial lung disease or non-infectious pneumonitis.
- •Driver Gene Mutations: NSCLC with known activating EGFR mutations or ALK fusion gene positivity.
- •Other Malignancies:
- •Excluded: History of other active malignancies within the past 2 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ (e.g., bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast).
- •Exception: Patients with other malignancies who have achieved complete remission for ≥2 years and do not require additional anti-tumor therapy during this study may be enrolled.
- •Compliance/Understanding: Medical, psychological, or physiological conditions that, in the investigator's judgment, prevent the patient from completing the study or understanding the study information.
- •Prior Immune Therapy: Previous treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other drug targeting T-cell co-stimulation or checkpoint pathways.
- •Active Viral Infection:
- •(1) Active Hepatitis B (HBsAg positive AND HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL).
- •(2) Active Hepatitis C (HCV antibody positive AND HCV RNA above the lower limit of detection).
- •13. HIV/AIDS: Known positive test for human immunodeficiency virus (HIV) or diagnosed acquired immunodeficiency syndrome (AIDS).
- •14. Allergy: Known history of hypersensitivity to sintilimab, any of the chemotherapy agents used, or any of their excipients.
- •15. Pregnancy/Lactation: Pregnant or breastfeeding women.
- •Metastatic Disease: Presence of supraclavicular lymph node metastasis or distant metastasis.
排除标准
- 未提供
研究组 & 干预措施
Experimental : neoadjuvant SBRT combined with immunochemotherapy
Experimental
干预措施: Stereotactic body radiotherapy (SBRT) (Radiation)
Experimental : neoadjuvant SBRT combined with immunochemotherapy
Experimental
干预措施: Sintilimab (Drug)
Experimental : neoadjuvant SBRT combined with immunochemotherapy
Experimental
干预措施: Paclitaxel (Drug)
Experimental : neoadjuvant SBRT combined with immunochemotherapy
Experimental
干预措施: Carboplatin (AUC 5) (Drug)
Experimental : neoadjuvant SBRT combined with immunochemotherapy
Experimental
干预措施: Pemetrexed 500 mg/m2 (Drug)
Experimental : neoadjuvant SBRT combined with immunochemotherapy
Experimental
干预措施: non-small cell lung cancer (Procedure)
结局指标
主要结局
Contralateral Mediastinal Lymph Node Downstaging Rate
时间窗: From the start of neoadjuvant therapy until post-surgical pathological assessment, approximately 12 weeks.
Surgical Conversion Rate
时间窗: From the start of neoadjuvant therapy until post-surgical pathological assessment, approximately 12 weeks.
次要结局
- Major Pathological Response Rate(At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.)
- Pathological Complete Response Rate(At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.)
- Event-Free Survival(From enrollment until the first occurrence of an EFS event, assessed up to 5 years.)
- R0 Resection Rate(At the time of surgical pathological assessment, approximately 12 weeks after the start of neoadjuvant therapy.)
- Overall Survival(From enrollment until death from any cause, assessed up to 5 years.)
- Incidence of Adverse Events(From the start of neoadjuvant therapy until 90 days after the last dose of study drug or 30 days after surgery, whichever is later.)
研究者
Yang Hong
Professor
Sun Yat-sen University
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