A Randomized, Phase III Umbrella Trial of Adjuvant Therapy Versus Observation in Completely Resected High-Risk Stage IA-IB Non-Small Cell Lung Cancer Based on Oncogenic Driver Mutations
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
This study explores how adjuvant therapy affects survival in completely resected high-risk stage IA-IB NSCLC patients with different driver gene mutations.
详细描述
This study aims to evaluate whether tailored, targeted therapy or immunotherapy can effectively prevent cancer recurrence in patients with early-stage (stage IA-IB) non-small cell lung cancer (NSCLC) who have undergone complete surgical resection but are at high risk of recurrence. Based on each patient's specific driver gene mutation status (e.g., EGFR or ALK/ROS1) or wild-type status, participants will receive either targeted therapy or immunotherapy compared to routine follow-up (observation). The goal is to see if these approaches can improve disease-free survival and potentially reduce the risk of lung cancer recurrence.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years and able to provide written informed consent.
- •Primary non-squamous NSCLC confirmed by pathology, with no brain metastases.
- •Complete R0 surgical resection (lobectomy, segmentectomy, or pneumonectomy) of stage IA or IB NSCLC (AJCC 8th edition).
- •High-risk disease (one or more): low differentiation, solid/micropapillary/complex glandular patterns, vascular invasion, visceral pleural invasion, alveolar space spread, or intermediate/high risk on 14-gene test.
- •Documented driver gene status (EGFR mutation, ALK/ROS1 fusion, or wild-type) via postoperative tumor sample.
- •ECOG performance status 0 or 1, with stable condition over the last two weeks.
- •Surgery within 4-10 weeks before starting treatment, with full recovery.
- •Adequate organ function as per protocol-defined labs.
- •Negative pregnancy test (if applicable) and use of effective contraception during and 3 months after treatment.
排除标准
- •Evidence of unresectable/metastatic NSCLC, incomplete resection (R1/R2), or wedge resection only.
- •Prior systemic therapy (e.g., chemotherapy, targeted therapy, immunotherapy) for the current NSCLC.
- •Major surgery (excluding lung cancer surgery) within 3 weeks before first study dose.
- •Planned concurrent anti-cancer therapy (chemo, radiotherapy, or targeted therapy) during the study.
- •Clinically significant cardiac disorders (e.g., poorly controlled hypertension, recent MI or stroke, prolonged QTc).
- •History or suspicion of interstitial lung disease requiring treatment.
- •Active or uncontrolled infection (e.g., hepatitis B with detectable HBV DNA, hepatitis C, HIV, active TB).
- •Severe GI conditions impairing drug absorption (e.g., Crohn's, ulcerative colitis).
- •Use of strong CYP3A inducers/inhibitors within 1 week or ongoing need for warfarin.
- •Participation in another interventional trial within 4 weeks or receipt of a live vaccine within 180 days.
- •Any condition that may compromise adherence or safety, per investigator judgment.
研究组 & 干预措施
Adjuvant therapy
干预措施: Icotinib (Drug)
Adjuvant therapy
干预措施: Rezivertinib (Drug)
Adjuvant therapy
干预措施: Ensartinib (Drug)
Adjuvant therapy
干预措施: Benmelstobart (Drug)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: From randomization until disease recurrence or death (up to approximately 5 years)
Disease-free survival (DFS) is defined as the time from randomization to the first documented disease recurrence (local relapse or distant metastasis confirmed by imaging or pathology) or death from any cause, whichever occurs first. Participants without documented recurrence or death at the time of analysis will be censored at their last disease assessment date.
次要结局
- Overall Survival (OS)(From randomization to death or last follow-up (up to approximately 5 years))
- Central Nervous System Disease-Free Survival (CNS DFS)(From randomization until CNS progression or death, whichever occurs first (up to approximately 5 years))
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From date of randomization up to approximately 5 years)
研究者
Jianxing He
Director, Head of Thoracic Surgery, Principal Investigator, Clinical Professor
The First Affiliated Hospital of Guangzhou Medical University