Treatment Strategy of Iparomlimab and Tuvonralimab Plus Chemotherapy for Inducing Conversion to Resectability in Initially Unresectable Stage III Non-Small Cell Lung Cancer: A Single-Arm Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 主要终点
- R0 Resection Rate
研究概览
简要总结
This is a single-arm, multicenter Phase II clinical study designed to observe and evaluate the efficacy and safety of Iparomlimab and tuvonralimab plus chemotherapy in initially unresectable Stage III NSCLC. The study plans to enroll 69 Stage III NSCLC patients judged unresectable by a MDT team, with the R0 resection rate as the primary endpoint.
After completing 2-4 cycles of conversion therapy, the MDT team reassesses resectability. Subjects deemed suitable for surgical resection undergo surgery within 6 weeks after the last dose of conversion therapy. Subjects deemed unsuitable for surgery receive radical chemoradiotherapy, starting within 6 weeks after the last conversion therapy dose. Subjects unsuitable for both surgery and chemoradiotherapy will have their subsequent treatment decided by the project team.
Adjuvant therapy consists of Iparomlimab and tuvonralimab monotherapy (Q3W) for up to 16 cycles.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed an informed consent form
- •Patients aged ≥18
- •Histologically or cytologically confirmed Stage III (AJCC 9th ed.) squamous or non-squamous NSCLC (mixed tumors classified by predominant cell type), deemed unresectable by the MDT team based on at least one of the following criteria:
- •Ipsilateral multi-station or confluent mediastinal lymph node metastasis: Imaging shows ipsilateral multi-station lymph node metastasis or confluent lymph node mass (>3cm diameter) or invasion of surrounding organs, making complete surgical clearance impossible.
- •Contralateral or supraclavicular lymph node metastasis (N3): This includes contralateral hilar and mediastinal lymph node metastasis, or ipsilateral/contralateral supraclavicular lymph node metastasis.
- •Invasion of vital organs or major vessels: Anatomical tumor or lymph node invasion directly involving the heart, major vessels (e.g., aorta, main pulmonary artery), trachea, esophagus, vertebral body (>50% involvement), or brachial plexus.
- •Extensive chest wall and pleural invasion: Involvement of ribs, intercostal muscles, and chest wall soft tissues is extensive, requiring large chest wall resection that the patient's pulmonary function cannot tolerate, or impossible to clear surgically.
- •Special anatomical location: e.g., superior sulcus tumor (Pancoast tumor) invading vertebrae/nerve plexus, recurrent laryngeal nerve involvement causing vocal cord paralysis, tumor extent precluding R0 resection.
- •Patient unable to tolerate lobectomy or pneumonectomy: Insufficient cardiopulmonary reserve, severe cardiovascular disease, coagulation dysfunction, or other systemic diseases precluding lobectomy or pneumonectomy.
- •at least one measurable lesion according to RECIST 1.1 criteria
- •Pulmonary function must meet: FEV1 > 1.0 L and FEV1%> 40%
- •appropriate organ function
排除标准
- •NSCLC with small cell component identified on pathology (regardless of proportion); Histological types of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC-NOS.
- •Known EGFR mutation or ALK rearrangement positivity (eligibility of subjects with other driver gene positivity will be determined by the project biomarker expert group).
- •Prior systemic anti-tumor therapy or thoracic radiotherapy.
研究组 & 干预措施
Iparomlimab and tuvonralimab plus chemotherapy
Patients will receive Iparomlimab and tuvonralimab (5 mg/kg) plus chemotherapy (nab-paclitaxel, pemetrexed, or docetaxel) every 3 weeks.
干预措施: Iparomlimab and tuvonralimab plus chemotherapy (Drug)
结局指标
主要结局
R0 Resection Rate
时间窗: 2 years
The proportion of patients who achieve complete tumor removal with no residual cancer cells at the surgical margin under microscopic examination after surgery
次要结局
- 2-year event-free survival (EFS) rate(2 years)
- Pathologic Complete Response (pCR)(2 years)
研究者
Chang Chen
professor
Shanghai Pulmonary Hospital, Shanghai, China