A Prospective, Randomized, Phase ll Clinical Trial of Single-agent Treatment With Different Doses of Sulfamethoxazole Furmonertinib in Patients With Advanced, Metastatic Lung Adenocarcinoma Who Have Progressed After First- or Second-line Treatment With EGFR-TKl Osimertinib
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic lung adenocarcinoma
- •Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
- •Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with Osimertinib; or previous genetic testing for a definite T790M mutation and imaging-confirmed extracranial lesion progression after second-line treatment with Osimertinib.
- •Pre-existing clinical benefit after treatment with Osimertinib, including CR, PR, SD (duration >6 months);
- •Patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
- •Normal functioning of major organs
- •Pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug
- •Subjects volunteered and signed a written informed consent form.
排除标准
- •Previous chemotherapy or immunotherapy
- •Patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types
- •Progression of imaging-confirmed extracranial lesions after prior Osimertinib treatment with accessible treatment options after genetic testing
- •Patients with symptomatic brain metastases, meningeal metastases or spinal cord compression
- •Any unrecovered CTCAE > grade 1 toxicity reaction following prior Osimertinib treatment at the start of study drug therapy
- •Other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc.
- •History of interstitial pneumonia with previous diagnosis
- •Other circumstances that, in the judgement of the investigator, make them unsuitable for inclusion in the study
研究组 & 干预措施
Group A: Furmonertinib 160mg QD
Furmonertinib (AST2818) 160mg QD. All patients enrolled into this group will receive furmonertinib 160mg daily.
干预措施: Furmonertinib (Drug)
Group B: Furmonertinib 240mg QD
Furmonertinib (AST2818) 240mg QD. All patients enrolled into this group will receive furmonertinib 240mg daily.
干预措施: Furmonertinib (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment
Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response
次要结局
- Progression-free survival (PFS)(The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study treatment)
- Disease Control Rate (DCR)(Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment)
- Duration of Response (DoR)(Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 12 months from the first patient begin study treatment)