Phase II, Single-Arm Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Atezolizumab for Patients With Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 8
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with atezolizumab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed ES-SCLC
- •No prior treatment for ES-SCLC
- •Measurable disease, as defined by RECIST v1.
- •Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
- •ECOG performance status of 0 or 1
- •Life expectancy >= 3 months
- •Adequate hematologic and end-organ function
- •For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
- •Negative human immunodeficiency virus (HIV) test at screening
- •Negative hepatitis B surface antigen (HBsAg) test at screening
- •Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test must be performed for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
- •Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test must be performed for participants who have a positive HCV antibody test.
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
排除标准
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •History of leptomeningeal disease
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Uncontrolled or symptomatic hypercalcemia
- •Active or history of autoimmune disease or immune deficiency
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •Active tuberculosis
- •Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- •History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
研究组 & 干预措施
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
干预措施: Atezolizumab (Drug)
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
干预措施: Cisplatin (Drug)
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
干预措施: Carboplatin (Drug)
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
干预措施: Etoposide (Drug)
LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + atezolizumab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).
干预措施: Thoracic radiation therapy (TRT) (Radiation)
结局指标
主要结局
Objective Response Rate
时间窗: Baseline up to approximately 36 months
Objective response rate (ORR), defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
次要结局
- Progression Free Survival (PFS)(Baseline to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to approximately 36 months))
- Duration of Response(Baseline to disease progression or death from any cause (whichever occurs first)(up to approximately 36 months))
- Disease Control Rate (DCR)(Baseline up to approximately 36 months)
- PFS Rate at 6 Months and 1 Year(Baseline up to 1 year)
- Percentage of Participants With Adverse Event(Baseline up to approximately 36 months)
- Overall Survival (OS)(Baseline until death (up to approximately 36 months))
- OS Rate at 1 Year and 2 Years(Baseline to 2 years or death, whichever occurs first.)