NCT04691063Enrolling By Invitation3 期
A Multi-center, Randomized, Double-blinded, Phase III Trial of SHR-1316 or Placebo in Combination With Chemo-radiotherapy in Patients With Limited-stage Small-cell Lung Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of SHR-1316 in combination with chemo-radiotherapy in patients with LS-SCLC.
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
- •Male or female, 18-75 years of age.
- •Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
- •ECOG PS 0~
- •At least 1 measurable lesion as defined by RECIST v1.
- •Adequate organ function.
- •Female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. And female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
- •Signed the informed consent form.
排除标准
- •Mixed SCLC or NSCLC.
- •Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
- •Extensive-stage SCLC.
- •Subjects who is surgically resectable.
- •Subjects with malignant pleural effusion.
- •Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function.
- •Active, known, or suspected autoimmune diseases.
- •History of malignant tumors.
- •Subjects with severe cardiovascular disease.
- •Events of arterial/venous thrombosis within 6 months prior to the first dose.
- •Subjects with serious infection.
- •Subjects with active pulmonary tuberculosis (TB).
- •Subjects with immunodeficiency diseases.
- •Subjects with active hepatitis B virus or hepatitis C virus infection.
- •Systemic immunosuppressants administation within 14 days prior to the first dose.
- •Subjects who received major surgery within 28 days prior to the first dose.
- •Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
- •Subjects who have previously received tissue/organ transplants.
- •Subjects with history of severe allergic reactions to monoclonal antibodies/fusion protein drugs.
- •Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR-1316; Carboplatin; Etoposide；Radiotherapy (Drug)
Treatment group B
Placebo Comparator
干预措施: Palcebo; Carboplatin; Etoposide；Radiotherapy (Drug)
结局指标
主要结局
OS
时间窗: up to 36 months
Overall Survival
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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