A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction With Platinum-Based Chemotherapy Combined With Durvalumab, for the First-Line Treatment of Patients With Extensive Stage Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 31
- 试验地点
- 13
- 主要终点
- Maintenance Participants Alive and Progression Free (APF12) Per RECIST 1.1 [Efficacy]
研究概览
简要总结
A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer.
详细描述
Primary objective of this study is to evaluate the efficacy of AZD2811 and durvalumab in patients who have not progressed following induction therapy with platinum-based chemotherapy combined with durvalumab.
This is an open-label, single arm study. Patients will be treated in an induction phase with platinum-based induction therapy and durvalumab. At the end of this induction period, participants will be assessed for disease progression, per RECIST v1.1.
Participants who have not progressed per RECIST v1.1 at the end of the induction phase will roll over into the maintenance phase of the trial, where patients will commence AZD2811 and durvalumab combination.
Participants will be treated with AZD2811 and durvalumab as maintenance therapy until confirmed progressive disease, start of non-protocol defined anticancer therapy, unacceptable toxicity, or withdrawal of consent.
If study intervention is permanently discontinued, the participant will remain in the study to be evaluated for safety assessment, as well as for confirmed disease progression and for survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented evidence of extensive stage SCLC (ES-SCLC)
- •Participants must be considered suitable to receive an induction platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
- •No prior exposure to immune-mediated therapy
- •Life expectancy ≥12 weeks at Day
- •ECOG 0 or 1 at enrolment.
排除标准
- •Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
- •Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
- •Active infection including tuberculosis, HIV, hepatitis B and C
- •Active or prior documented autoimmune or inflammatory disorders
- •Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
研究组 & 干预措施
AZD2811 + Durvalumab
Induction:
Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin & Etoposide)
Maintenance:
AZD2811 + Durvalumab
干预措施: Durvalumab (Drug)
AZD2811 + Durvalumab
Induction:
Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin & Etoposide)
Maintenance:
AZD2811 + Durvalumab
干预措施: Etoposide (Drug)
AZD2811 + Durvalumab
Induction:
Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin & Etoposide)
Maintenance:
AZD2811 + Durvalumab
干预措施: Cisplatin (Drug)
AZD2811 + Durvalumab
Induction:
Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin & Etoposide)
Maintenance:
AZD2811 + Durvalumab
干预措施: Carboplatin (Drug)
AZD2811 + Durvalumab
Induction:
Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin & Etoposide)
Maintenance:
AZD2811 + Durvalumab
干预措施: AZD2811 (Drug)
结局指标
主要结局
Maintenance Participants Alive and Progression Free (APF12) Per RECIST 1.1 [Efficacy]
时间窗: Up to 12 months
12 month landmark PFS, APF12, where PFS is defined as the time from the first dose of study intervention in the induction phase until objective disease progression (as assessed by the investigator per RECIST v1.1) or death from any cause, whichever comes first.
次要结局
- Maintenance Participants Alive at 12 Months (OS12), 15 Months (OS15), and 18 Months (OS18)(Up to 18 months)
- Maintenance Participants Alive and Progression Free at 6 Months (APF6) and 9 Months (APF9) Using Investigator Assessments According to RECIST 1.1(Up to 9 months)
- Objective Response Rate (ORR) for All Participants Using Investigator Assessments According to RECIST 1.1(Up to approximately 10 months)
- Maintenance Participants Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1(Up to approximately 10 months)
- Overall Survival (OS) in Maintenance Participants(Up to approximately 13 months)
- AZD2811 PK: Pharmacokinetics of AZD2811 and Its Metabolites by Measuring Whole Blood Concentration(Up to Cycle 8 Day 8 (approximately 5 months))
- EORTC 30: Health Related Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cancer (QLQ-C30) v3.0.(Up to Cycle 10 Day 1, approximately 7 months)
- EORTC 13: Lung Cancer Specific Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Lung Cancer (QLQ-LC13) v1.0.(Up to Cycle 10 Day 1, approximately 7 months)
- EORTC 13: Lung Cancer Specific Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Lung Cancer (QLQ-LC13) v1.0. Use of Pain Medication (Yes/No)(Up to Cycle 10 Day 1, approximately 7 months)