NCT05011487招募中2 期
Neoadjuvant Osimertinib Plus Chemotherapy for EGFR-mutant Stage III N2 Non-squamous Non-small Cell Lung Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complete lymph node clearance rate
研究概览
简要总结
This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer
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
- •Histologically or cytologically documented N2 positive non-squamous NSCLC with resectable (Stage IIIA or T3-4N2 IIIB) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).
- •Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures).
- •Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
- •A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).
排除标准
- •Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- •History of another primary malignancy, except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease
- •Patients who have pre-operative radiotherapy treatment as part of their care plan
- •Mixed small cell and NSCLC histology
- •T4 tumours infiltrating the aorta, the oesophagus and/or the heart; and/or any bulky N2 disease deemed unresectable
- •Patients who are candidates to undergo only segmentectomies or wedge resections
- •Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
- •Prior treatment with EGFR-TKI therapy
- •Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)
研究组 & 干预措施
osimertinib plus chemotherapy
Experimental
Osimertinib (80mg/qd) po. for 60 days with two cycles of Pemetrexed (500 mg/m2) to be administered with cisplatin (75mg/m2) on Day 1 of every 3-week cycle for 2 cycles
干预措施: Osimertinib (Drug)
osimertinib plus chemotherapy
Experimental
Osimertinib (80mg/qd) po. for 60 days with two cycles of Pemetrexed (500 mg/m2) to be administered with cisplatin (75mg/m2) on Day 1 of every 3-week cycle for 2 cycles
干预措施: Cisplatin (Drug)
osimertinib plus chemotherapy
Experimental
Osimertinib (80mg/qd) po. for 60 days with two cycles of Pemetrexed (500 mg/m2) to be administered with cisplatin (75mg/m2) on Day 1 of every 3-week cycle for 2 cycles
干预措施: Pemetrexed (Drug)
结局指标
主要结局
complete lymph node clearance rate
时间窗: From date of enrollment to an average of 12 weeks after the first dose
the ratio of ypN0 percentage after resection
次要结局
- Major Pathological Response (MPR)(From date of enrollment to an average of 12 weeks after the first dose)
- Disease free survival (DFS)(From date of enrollment up to approximately 42 months after date of resection)
- Pathological complete response (pCR)(From date of enrollment to an average of 12 weeks after the first dose)
- Downstaging(From date of enrollment to an average of 12 weeks after the first dose)
研究者
Yang Hong
Prof.
Sun Yat-sen University
研究点 (1)
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