NCT04206072已完成2 期
A Phase II/III, Open-Label, Randomised Study to Assess the Safety and Efficacy of D-0316 Versus Icotinib as First Line Treatment in Patients With EGFR Sensitising Mutation, Locally Advanced or Metastatic NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 2
- 主要终点
- Median Progression Free Survival (PFS) assessed by IRC
研究概览
简要总结
To assess the efficacy and safety of D-0316 versus Icotinib, a standard of care epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), in patients with locally advanced or Metastatic Non Small Cell Lung Cancer (NSCLC).
详细描述
This is a Phase II/III, open-label, randomised study assessing the efficacy and safety of D-0316 (70 mg once daily for 21 days, then increased to 100 mg once daily, orally) versus Icotinib (125 mg three times daily, orally) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitising mutation (EGFRm) positive, treatment-naive and eligible for first-line treatment with an EGFR-TKI.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older.
- •Pathologically confirmed adenocarcinoma of the lung, with locally advanced or metastatic disease and not amenable to curative surgery or radiotherapy (stage IIIB, IIIC or IV disease based on the eighth edition of the American Joint Committee on Cancer (AJCC) TNM classification). Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
- •Patients must be treatment-naive for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with icotinib. Prior adjuvant and neo-adjuvant therapy (except for EGFR-TKI) is permitted if have been completed at least 6 months prior to initiation of study drug.
- •The tumour tissues harbour one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by central laboratory.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Predicted survival ≥ 3 months
- •At least 1 measurable tumor lesion as per RECIST v1.1
- •Agree to use effective contraception during the study period and for at least 3 months after completion of the study treatment
- •Provision of informed consent prior to any study procedure.
排除标准
- •Evidence of any concurrent or history of malignancy (except for clinically cured in situ cervix carcinoma, basal cell or squamous epithelial skin cancer, thyroid papillary carcinoma).
- •Prior treatment with EGFR-TKI.
- •Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC including chemotherapy, biological therapy, immunotherapy, and etc.
- •Previous therapeutic clinical trial with 4 week of the first dose of study drug.
- •Previous traditional chinese medicine with an anti-cancer indication within 2 weeks of the first dose of study drug.
- •Previous major surgery (except for tooth extraction) within 4 weeks of the first dose of study drug, planing to have major surgery during study.
- •Symptoms or signs worsened within 2 weeks before screening.
- •Any unresolved toxicities from prior treatment greater than NCI CTCAE v4.03 grade 2 or higher, with the exception of hair loss.
- •Spinal cord compression, symptomatic or unstable central nervous system (CNS) metastases that require the use of steroids. Patients who have a stable CNS status for at least 4 weeks before treatment will be allowed to join the study.
- •Any evidence of serious or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding diatheses, or active infection including hepatitis B, hepatitis C, syphilis and human immunodeficiency virus (HIV).
- •Clinically significant cardiovascular disease, such as mean resting corrected QT interval (QTcF) ≥470 msec (female) or ≥450 msec (male), obtained from 3 ECGs, or any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG or left ventricular ejection fraction (LVEF) ≤ 50%, etc.
- •Previous history of interstitial lung disease, drug-induced interstitial lung disease, history of radiation-induced pneumonia requiring hormone therapy, or clinical evidence of active interstitial lung disease.
- •Presence of active gastrointestinal disease or other condition that would preclude the absorption, distribution, metabolism, or excretion of study drug.
- •Patients currently receiving medications known to be potent inducers, sensitive substrate or potent inhibitor of cytochrome P450 (CYP) 3A4 (e.g. CYP3A4), CYP3A5, CYP2D6 and CYP2C
- •Patients with a known allergy or delayed hypersensitivity reaction to study drug or its excipient.
研究组 & 干预措施
D-0316
Experimental
D-0316 (75 mg or 100 mg orally, once daily), in accordance with the randomization schedule.
干预措施: D-0316 Capsule (Drug)
Icotinib
Active Comparator
Icotinib (125 mg orally, three times daily), in accordance with the randomization schedule.
干预措施: Icotinib Hydrochloride Tablets (Drug)
结局指标
主要结局
Median Progression Free Survival (PFS) assessed by IRC
时间窗: From randomization to objective disease progression or death, whichever came first, assessed up to 20 months
PFS is defined as the time from randomization until the date of objective disease progression or death by any cause, whichever occurs first. The primary endpoint of PFS was based on independent review committee (IRC) assessment.
次要结局
- Median Progression Free Survival (PFS) assessed by Investigator(From randomization to objective disease progression or death, whichever came first, assessed up to 20 months)
- Objective Response Rate (ORR)(At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months)
- Duration of Response (DoR)(At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months)
- Disease Control Rate (DCR)(At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months)
- Overall Survival (OS)(From randomization to date of death from any cause, whichever came first, up to 36 months)
- Intracranial PFS (iPFS)(From randomization to objective intracranial disease progression or death, whichever came first, up to 20 months)
- Intracranial ORR (iORR)(At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months)
- Adverse event (AE)(At baseline and every 3 weeks (±4 days) for the first 6 weeks, and then every 6 weeks (±4 days) until objective disease progression or meet other withdrawal criteria, up to 36 months)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
HMPL-813 in Treating Patients With GlioblastomaGlioblastomaNCT03231501Hutchison Medipharma Limited29
已完成
1 期
Dasatinib In Combination With Trastuzumab And Paclitaxel In First Line Treatment Of Her2-Positive MBC PatientsMetastatic Breast CancerNCT01306942Spanish Breast Cancer Research Group37
进行中（未招募）
3 期
ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLCLocally Advanced or Metastatic NSCLCNCT04143607Jiangsu Aosaikang Pharmaceutical Co., Ltd.337
Unknown
3 期
A Study of SH-1028 Tablets Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung CancerNon-Small Cell Lung CancerNCT04239833Nanjing Sanhome Pharmaceutical, Co., Ltd.240
已完成
3 期
Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) PatientsNon-small Cell Lung CancerNCT01040780Betta Pharmaceuticals Co., Ltd.399