A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to Progression
研究概览
简要总结
This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).
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
- •Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months；
- •Locally advanced or metastatic NSCLC diagnosed by histology or cytology
- •The major organs are functioning well；
- •Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study；
- •Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.
排除标准
- •Current concomitant presence of other malignancies within 5 years prior to the first dose;
- •Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;
- •Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
- •Long-term unhealed wounds or fractures;
- •Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
- •A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
- •Subjects with any severe and/or uncontrolled disease;
- •History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
- •Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928 injection or excipients in pharmaceutical formulations;
- •According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
研究组 & 干预措施
TQB2928 injection + Almonertinib Mesilate Tablets
Every 3 weeks constitutes one treatment cycle. For the first 2 cycles, TQB2928 is administered via infusion once a week. Starting from the 3rd cycle, TQB2928 is administered once every 3 weeks. Amivantamab is taken orally at a fixed time daily.
干预措施: TQB2928 injection + Almonertinib Mesilate Tablets (Drug)
结局指标
主要结局
Time to Progression
时间窗: Up to 2 years
The time from randomization to obtaining the first objective relief.
Phase II recommended combination doses (RP2CD)
时间窗: Baseline up to 24 months
The recommended dosage for drug combination therapy in the second phase of clinical trials (i.e. Phase II clinical trials).
Objective Response Rate (ORR)
时间窗: Up to 2 years
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Duration of Response (DOR)
时间窗: Up to 2 years
Defined as the time from first documented response to documented disease progression.
Progression-free survival (PFS)
时间窗: Up to 2 years
Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.
次要结局
- Elimination half-life (t1/2)(Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks))
- Area under the plasma concentration-time curve (AUC0-last)(Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks))
- Apparent Plasma Clearance (CL)(Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks))
- Apparent volume of distribution(Vz)(Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks))
- Steady-state trough concentration (Css-min)(Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks))
- Immunogenicity: anti-drug antibody (ADA)(From the time of informed consent signed through 90 days after the last dose)
- Adverse Events (AE) rate(From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first)