NCT03822351已完成2 期
A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
研究概览
简要总结
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
详细描述
Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
- •Age 18 years or older
- •Body weight ≥ 35 kg
- •Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
- •Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study
- •Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
- •Life expectancy ≥ 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1
排除标准
- •Mixed small cell and non-small cell lung cancer histology
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug
- •Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC
- •Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
- •Subjects with a history of venous thrombosis within the past 3 months
- •Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
- •Congestive heart failure
- •Active or prior documented autoimmune or inflammatory disorders
- •History of active primary immunodeficiency
- •Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- •History of allogenic organ transplantation
- •QTcF interval ≥ 470 ms
- •History of another primary malignancy
- •Concurrent enrollment in another clinical study [concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted]
- •Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
研究组 & 干预措施
Control Arm (Durvalumab monotherapy)
Experimental
durvalumab IV
干预措施: Durvalumab (Drug)
Arm A (durvalumab + oleclumab):
Experimental
durvalumab IV and oleclumab IV
干预措施: Durvalumab + Oleclumab (Drug)
Arm B (durvalumab + monalizumab)
Experimental
durvalumab IV and monalizumab IV
干预措施: Durvalumab + Monalizumab (Drug)
结局指标
主要结局
Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
时间窗: ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint
ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
次要结局
- Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents(From time of signature of informed consent up to 15 months post the first dose of study treatment)
- Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents(From baseline up to 15 months post the first dose of study treatment)
- Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents(From baseline up to 15 months post the first dose of study treatment)
- Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents(Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).)
- Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents(Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).)
- Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents(Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).)
- Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents(PFS rate at 12 months after randomization.)
- Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents(From time of randomization until death due to any cause. Assessed through the database cutoff date of 18-Jul-2023).)
- Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents(From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1)
- Pharmacokinetics of Novel Agents in Combination With Durvalumab(From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1)
- Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents(From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1)
- Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab(From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1)
研究者
研究点 (1)
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