A Phase II, Multicenter Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR Mutation Positive Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Chemoradiation Therapy (PLATINUM Trial)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 77
- 试验地点
- 13
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The "PACIFIC" trial confirmed that the consolidation therapy with durvalumab in patients with stage III, locally advanced, unresectable NSCLC that had not progressed after definitive platinum-based chemoradiation therapy improved the progression-free survival (PFS) by about 17 months. However, in PACIFIC, no significant differences between durvalumab and placebo were observed in PFS. Unmet need remains in development of successful consolidation therapy following chemoradiation therapy in patients with EGFR-mutant stage III unresectable NSCLC.
A recent "ADAURA" study showed that Osimertinib as an adjuvant therapy after surgery significantly prolonged disease-free survival in EGFR mutation-positive patients. Lazertinib, like Osimertinib, is a third-generation EGFR TKI agent and has shown excellent anticancer effects in preclinical studies and in early clinical settings. Based on these results of the 3rd generation EGFR TKI, Lazertinib, it is expected that there is a clinical benefit Lazertinib as consolidation therapy.
This study aims to investigate the clinical benefits of Lazertinib (Trade name: LECLAZA Tab) consolidation therapy for patients with EGFR mutation-positive, unresectable stage III NSCLC after definitive platinum-based chemoradiation therapy.
详细描述
This study is designed as a prospective, open-label, single-arm, multicenter, phase II, investigator-initiated trial. A total of 77 patients will participate in the study who have undergone definitive platinum-based concurrent chemoradiation therapy and have no disease progression. Patients are to be enrolled within 1 to 42 days after concurrent chemoradiation therapy and to be administrated with lazertinib 240mg oral once daily until disease progression, or unacceptable toxicity. Patients will visit every 8 weeks and perform CT/MRI tumor evaluation by investigator, and will be followed up for survival every 3 months by phone thereafter. Patients will be followed up till maximum of appropriately 4 years of which 3 years since the last patient enrollment must be.
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
- •18 years and older
- •Histologically and cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) non-squamous cell carcinoma who present with locally advanced, unresectable, Stage III disease
- •ECOG PS 0,1
- •Expected life expectancy of 6 months and more
- •Patients who have received at least 2 cycles of definitive platinum-based concurrent chemoradiation therapy (CCRT) and who must be within 1 to 42 days after completion of radiation therapy
- •Patients must not have had disease progression during or following CCRT
- •Patients with adequate organ and bone marrow function
- •Patients who give in written consent voluntarily to participate in this study
排除标准
- •History of interstitial lung disease, drug-induced interstitial lung disease, or radiation interstitial pneumonia
- •History of other primary malignancy
- •Mixed small cell and NSCLC histology
- •Prior treatment with EGFR-TKI Therapy
- •Unresolved toxicity of CTCAE grade 2 or higher following chemoradiation
- •Current history of CTCAE grade 2 or higher pneumonia prior to chemoradiation therapy
- •Patients with severe hypersensitivity to active ingredient or excipient of the investigational medicinal product
- •Pregnant or breastfeeding patients
- •Patients who do not agree to contraception with medically acceptable method for at least 6 months after the end of study intervention treatment
- •Patients who participated in clinical trials within 4 weeks before participating in this study
- •Judgment by the investigator that the patient is unsuitable to participate in this study
研究组 & 干预措施
Lazertinib
Lazertinib 240mg, oral, QD
干预措施: Lazertinib (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
The time from the date of enrollment until the date of disease progression or death (by any cause in the absence of progression) Per RECIST 1.1 as assessed by Investigator.
次要结局
- Objective response rate (ORR)(Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years))
- Safety profile : Adverse Events according to CTCAE V5.0(every visit (up to maximum of approximately 4 years))
- Time to death or distant metastasis (TTDM)(Until death or distant metastasis (up to maximum of approximately 4 years))
- Duration of response (DoR) Duration of response (DoR)(Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years))
- Overall survival (OS)(Until death (up to maximum of approximately 4 years))
研究者
Sung Yong Lee
Professor
Korea University Guro Hospital