A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The rate of NSCLC converting to resectable tumors
研究概览
简要总结
This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
详细描述
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.
The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).
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
- •Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator.
- •Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation
- •ECOG Performance Status of 0-1
- •At least one measurable lesion according to RECIST 1.1
- •Adequate organ and marrow function
排除标准
- •Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma
- •The presence of malignant pleural effusion
- •Prior systemic anti-cancer therapy for non-small cell lung cancer
- •Prior local radiotherapy for NSCLC
- •Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment
研究组 & 干预措施
Afatinib plus chemotherapy
Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment (afatinib 40mg qd; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for non-squamous carcinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then surgery will be provided for patients who are suitable for primary tumor resection. Maintenance treatment with afatinib 40mg qd will continue up to 2 years or disease progression after surgery.
干预措施: Afatinib plus chemotherapy as conversion treatment (Drug)
结局指标
主要结局
The rate of NSCLC converting to resectable tumors
时间窗: Up to 12 weeks
The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.
次要结局
- R0 resection rate(immediately after the surgery)
- Major pathologic response (MPR) Rate(Up to 12 weeks)
- Pathologic complete response (pCR) Rate(Up to 12 weeks)
- Tumor downstaging rate(Up to 12 weeks)
- Objective response rate (ORR)(Up to five years)
- Disease control rate (DCR)(Up to five years)
- Event-free survival (EFS)(Up to five years)
- The 2-year progression-free survival (PFS) rate(Up to two years)
- Overall Survival (OS)(Up to five years)