NCT05503888尚未招募1 期
An Open-label, Multicenter Phase Ib/II Clinical Study of Almonertinib Combined With SHR-1701 or Other Innovative Drugs in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer With EGFR Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Dose limiting toxicity （Phase Ib）
研究概览
简要总结
To evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of Almonertinib combined with SHR-1701 in relapsed or advanced NSCLC To evaluate the efficacy of Almonertinib combined with SHR-1701 in the first-line treatment of relapsed or advanced NSCLC
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Patients voluntarily joined the study and signed informed consent
- •Age 18~75 years old, both male and female
- •Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy
- •At least one measurable lesion based on RECIST v1.1 criteria
- •ECOG PS score: 0-1
- •Have a life expectancy of at least 3 months
- •Fertile women must have a negative serum pregnancy test within 3 days before the first dose and must be non-lactating
排除标准
- •Untreated Brain metastases with clinical symptoms; Or accompanied by meningeal metastasis, spinal cord compression，etc.
- •Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms
- •Suffering from other malignant tumors in the past 3 years or at the same time
- •Presence of any active or known autoimmune disease
- •Subjects who had been systematically treated with corticosteroids (>10 mg/ day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose (randomization)
- •Any severe or uncontrolled ocular lesions that, in the judgment of the investigator, may increase the subject's safety risk
- •Have clinical symptoms or diseases of the heart that are not well controlled
- •Patients with hypertension who are not well controlled by antihypertensive medication
- •Any bleeding event of grade 2 or more or hemoptysis (volume of hemoptysis ≥2ml in a single episode) occurring within 2 weeks before the first dose (randomization); Clinically significant bleeding symptoms or definite bleeding tendency before the first medication (randomization)
- •Have known history of serious infections within 1 month prior to the first dose(randomization), including but not limited to infectious complications that require hospitalization, bacteremia, and severe pneumonia; use antibiotics within 1 week prior to the first dose(randomization); have any active infections requiring intravenous systemic therapy, or have a fever > 38.5°C of unknown cause before the first dose(randomization).
- •Have active or prior documented interstitial pneumonia/interstitial lung disease or pneumonitis that requires glucocorticoid treatment (e.g., radiation pneumonitis); Have active pneumonia at present
- •Have active pulmonary tuberculosis.
- •Have known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). Have known active hepatitis B or C.
- •Had received lung radiation therapy within 6 months before the first dose (randomization); Had received major surgical treatment (except diagnostic surgery), systemic chemotherapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first medication (randomization); Received palliative radiotherapy within 2 weeks before the first dose (randomization); Oral administration of molecular targeted drugs, less than 5 half-lives before discontinuation of the drug to the first dose (randomization); Failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE grade≤1
研究组 & 干预措施
Almonertinib combined with SHR-1701
Experimental
干预措施: Almonertinib combined with SHR-1701 (Drug)
Almonertinib
Placebo Comparator
干预措施: Almonertinib (Drug)
结局指标
主要结局
Dose limiting toxicity （Phase Ib）
时间窗: 21 days after the first dose
The incidence and severity of ≥ grade 3 treatment-related adverse events (TRAE) and serious adverse events (TRSAE) in the combination of two drugs （Phase Ib）
时间窗: from the time when all informed subjects signed the informed consent to the end of the safety follow-up period
PFS rate at 12 months
时间窗: 12 months after the first medication for the last subject
Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
次要结局
- PFS(up to 3 years)
- Adverse Events and Serious Adverse Events(up to 3 years)
- Proportion of dose pauses, dose downgrades and dose terminations due to study-drug related toxicities during the trial(up to 3 years)
- ORR(up to 3 years)
- DCR(up to 3 years)
- DoR(up to 3 years)
- DepOR(up to 3 years)
- OS(up to 5 years)
研究者
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