NCT05132413尚未招募3 期
A Phase 3, Randomized Double-blind, Placebo-controlled, Multicenter Study of SHR-1701 in Combination With Bevacizumab and Chemotherapy in Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer With EGFR Mutation After Failure of TKIs
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 561
- 主要终点
- Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I）
研究概览
简要总结
Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •A subject must satisfy all of the following criteria to be considered for inclusion in the study:
- •Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
- •Failed with prior EGFR-TKIs treatments.
- •Measurable disease, as defined by RECIST v1.1
- •The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
- •Life expectancy ≥ 3 months
- •Adequate hematologic and end-organ function as defined in the protocol
排除标准
- •A subject who meets any of the following criteria will be excluded from study entry:
- •Histologically or cytologically confirmed mixed SCLC and NSCLC.
- •Symptomatic, untreated or active central nervous system metastases.
- •Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
- •With any active autoimmune disease or history of autoimmune disease.
- •Inadequately controlled hypertension.
- •Tumour infiltration into the great vessels on imaging.
- •History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
- •Uncontrolled tumour-related pain.
- •Patients with active hepatitis B or hepatitis C
- •Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.
研究组 & 干预措施
treatment group
Experimental
干预措施: SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab (Drug)
Placebo group 1
Placebo Comparator
干预措施: Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin (Drug)
Placebo group 2
Placebo Comparator
干预措施: Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I）
时间窗: 2 years
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）
时间窗: 2 years
次要结局
- Progression free survival (PFS)（Stage II）(2 years)
- Progression free survival (PFS)（Stage I）(2 years)
- Objective response rate (ORR)（Stage I）(2 years)
- Disease control rate (DCR) （Stage I）(2 years)
- Duration of response (DOR) （Stage I）(2 years)
- Overall survival (OS) （Stage I）(2 years)
- Objective response rate (ORR)（Stage II）(2 years)
- Disease control rate (DCR)（Stage II）(2 years)
- Duration of response (DOR) （Stage II）(2 years)
- Overall survival (OS) （Stage II）(2 years)
- Incidence and severity of adverse events (AEs), serious adverse events （Stage II）(2 years)
- (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II）(2 years)
研究者
相似试验
已完成
3 期
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously TreatedAdenocarcinoma of the ColonAdenocarcinoma of the RectumRecurrent Colon CancerRecurrent Rectal CancerStage III Colon CancerStage III Rectal CancerStage IV Colon CancerStage IV Rectal CancerNCT00025337National Cancer Institute (NCI)880
尚未招募
2 期
SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain MetastasesBrain MetastasisTNBCNCT06210438Fudan University24
已完成
3 期
Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By SurgeryStage IB Lung Non-Small Cell Carcinoma AJCC v7Stage IIA Lung Non-Small Cell Carcinoma AJCC v7Stage IIB Lung Non-Small Cell Carcinoma AJCC v7Stage IIIA Lung Non-Small Cell Cancer AJCC v7NCT00324805National Cancer Institute (NCI)1,501
招募中
2 期
Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + BevacizumabOvarian, Fallopian Tube and Primary Peritoneal CarcinomaNCT06141265Peking University Cancer Hospital & Institute116
终止
2 期
Bevacizumab in Combination With Chemotherapy in the Neo-adjuvant Setting for HER2 (-) Breast CancerBreast CancerNCT01985841Hellenic Oncology Research Group34