NCT07039656招募中2 期
Toripalimab Combined With Chemotherapy as Postoperative Adjuvant Therapy for Non-Small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy: A Two-Cohort, Multicenter Phase II Trial
Wen-zhao ZHONG1 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2025年1月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- 2-year Disease-Free Survival
研究概览
简要总结
This is a two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS).
Researchers will compare outcomes between two cohorts:
- Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy;
- Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Patient with age ≥ 18 and ≤75 years old, gender is not limited.
- •Cohort 1: Histological diagnosis of Stage IB -IIIB NSCLC without anti-cancer treatment; Cohort 2: Histological diagnosis of Stage IIB-III NSCLC with non-MPR or MPR but lymph node positivity after neoadjuvant chemoimmunotherapy; (per American Joint Committee on Cancer staging system (AJCC) staging system, 8th edition)
- •Participants must have had complete resection of NSCLC 60 days
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Adequate organ function performed within 10 days of treatment initiation
- •Male or female patients of childbearing potential will voluntarily use an effective method of contraception, e.g., double-barrier contraception, condoms, oral or injectable contraceptives, IUDs, etc., during the study period and for the last 6 months of study drug use. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, artificially menopausal or sterilised (e.g. hysterectomy, bilateral adnexectomy or radiation ovarian irradiation).
排除标准
- •Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;
- •Treatment with prior systemic chemotherapy at any time
- •Confirmed EGFR or ALK mutations
- •Patient has a history of active autoimmune disease or autoimmune disease that may recur
- •Active hepatitis B and C patients will need to be on relevant antiviral therapy, have HBV-DNA <2000 IU/ml (<104 copies/ml) and have received anti-HBV therapy for at least 14 days prior to study participation, and continue therapy for the duration of the treatment period; HCV RNA-positive patients must be on antiviral therapy and have a liver function that is within the elevated CTCAE grade 1;
- •Known allergy to chemotherapy drugs including cisplatin, paclitaxel, albumin-paclitaxel and pemetrexed;
- •History of allergy to monoclonal antibody drugs
- •Patients with previous allogeneic stem cell or parenchymal organ transplantation
- •Having a mental illness or any other condition that renders treatment non-compliant
- •Patients unable or unwilling to sign the informed consent form
- •The investigator considered that the patient's condition may affect compliance with the protocol or make participation in this study unsuitable.
研究组 & 干预措施
Stage IB-IIIB participants following completely resection without neoadjuvant therapy
Experimental
干预措施: Toripalimab (Drug)
Stage IB-IIIB participants following completely resection without neoadjuvant therapy
Experimental
干预措施: Cisplatin-based chemotherapy (Drug)
Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy
Experimental
干预措施: Toripalimab (Drug)
Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy
Experimental
干预措施: Cisplatin-based chemotherapy (Drug)
结局指标
主要结局
2-year Disease-Free Survival
时间窗: 24 months
DFS was defined as the time from the start of the treatment to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
次要结局
- Overall Survival(60 months)
- Adverse events(24 months)
研究者
Wen-zhao ZHONG
Head of Thoracic Surgery
Guangdong Provincial People's Hospital
研究点 (1)
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