NCT05910034尚未招募2 期
The Study of Envafolimab Plus Docetaxel in Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC Previously Treated With a PD-1 Inhibitor Combined With Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 132
- 主要终点
- PFS
研究概览
简要总结
To evaluate the efficacy and safety of Envafolimab Plus Docetaxel in combination with or without Trilaciclib versus docetaxel IN patients with advanced non-small cell lung cancer previously treated with a PD-1 inhibitor combined with chemotherapy
详细描述
Trilaciclib indication: Trilaciclib, a CDK4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression, approved by FDA and NMPA for small cell lung cancer in 2021 and in 2022.
Envafolimab indication: Envafolimab, a PD-L1 inhibitor, was used for unresectable or metastatic, MSI-H or dMMR, Adult patients with advanced solid tumors, approved by NMPA in 2021.
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 subjects aged≥ 18 years old
- •Metastatic or advanced (stage IV) NSCLC confirmed by tissue or pathology
- •Patients with advanced NSCLC who had previously failed treatment with platinum-containing chemotherapy combined with PD-1 inhibitor
- •Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).,and has at least one measurable lesion
- •Patients with asymptomatic brain metastasis or whose symptoms are stable after treatment
- •Patients who responded to initial therapy or whose disease was stable for at least 3 months
- •Laboratory tests met the following criteria:
- •Hemoglobin (Hb)≥100 g/L(female), ≥110g/L(male)
- •Neutrophils (ANC)≥1.5×109/L
- •platelet count (PLT)≥100×109/L
- •Cr≤ 15mg/L or CrCl≥ 60 mL/min
- •TBIL≤ 1.5×ULN
- •ALT and AST ≤ 3 × ULN or ≤5× ULN(patients with liver metastases)
- •Albumin ≥ 30 g/L
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
- •Estimated life expectancy of more than 12 weeks
- •Women: All women with potential fertility must have negative serum pregnancy tests during the screening period and must have reliable contraception after signing the informed consent form until 3 months after the last dose
- •Already signed an informed consent form
排除标准
- •Diagnosis of other malignancies than NSCLC within 5 years prior to the first dose administration (excluding radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ)
- •Toxicity not recovered to ≤ Grade 1 from prior anticancer therapy
- •Previous treatment with PD-L1 inhibitors
- •≥grade 3 immune-related adverse reactions have occurred during previous PD-1 inhibitors treatment
- •Patients with known or suspected interstitial pneumonia
- •Patients with known positive driving genes(EGFR,ALK,ROS1)
- •Have used or requirement of treatment with prednisone > 10 mg/day or equivalent systemic corticosteroids within 14 days prior to the first dose of study drug
- •Administration of live attenuated vaccines within 28 days prior to the first study drug treatment or planned administration during the study
- •Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV)
- •Have stroke or cardiovascular events within 6 months prior to enrollment
- •QTcF>480 msec or QTcF>500 msec(patients with ventricular pacemakers)
- •Patients who have received hematopoietic stem cell or bone marrow transplants
- •Allergic to the study drug or its ingredients
- •Any other circumstances in which the researcher believes that the patient is not suitable to participate in this study
研究组 & 干预措施
Docetaxel
Experimental
Docetaxel: 75mg/m2 IV d1, Q3W
干预措施: Docetaxel (Drug)
Trilaciclib+Envafolimab+Docetaxel
Experimental
Trilaciclib:240mg/m2 IV d1,within 4h before chemotherapy; Envafolimab:300mg SC d1,Q3W; Docetaxel:75mg/m2 IV d1, Q3W
干预措施: Trilaciclib+Envafolimab+Docetaxel (Drug)
Envafolimab+Docetaxel
Experimental
Envafolimab:300mg SC d1,Q3W; Docetaxel:75mg/m2 IV d1, Q3W
干预措施: Envafolimab+Docetaxel (Drug)
结局指标
主要结局
PFS
时间窗: 12 months after the last subject participating in
Progression-free survival (PFS per RECIST 1.1) is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
次要结局
- DoR(12 months after the last subject participating in)
- ORR(12 months after the last subject participating in)
- DCR(12 months after the last subject participating in)
- OS(24 months after the last subject participating in)
- QOL(24 months after the last subject participating in)
- The incidence of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0(24 months after the last subject participating in)
研究者
Jialei Wang
professor of medicine
Fudan University
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