A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum observed serum concentration (Cmax)
研究概览
简要总结
This study has 2 parts: dose finding and dose confirmatory.
In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up
In Part 2, the dose confirmation phase of the study, participants will receive the dose of durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin. Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally, up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy) will be enrolled for a 12 treatment period and a 3 month follow-up period.
AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented unresectable Stage III NSCLC that has not progressed following definitive platinum based CRT or extensive disease (Stage IV) SCLC
- •ECOG performance status of 0 or 1
- •For participants with SCLC: At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL at baseline
- •Absence of EGFR mutation or ALK rearrangement prior to screening
排除标准
- •History of allogeneic organ transplantation
- •Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome
- •Uncontrolled intercurrent illness
- •History of another primary malignancy
- •History of active primary immunodeficiency
- •Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- •Brain metastases or spinal cord compression
- •Persistent toxicities (CTCAE Grade >2) caused by previous anticancer therapy, excluding alopecia
- •Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
研究组 & 干预措施
Patients with SCLC
Patients with Small Cell Lung Cancer
干预措施: Carboplatin (Drug)
Patients with NSCLC
Patients with Non-Small Cell Lung Cancer
干预措施: Durvalumab (Drug)
Patients with SCLC
Patients with Small Cell Lung Cancer
干预措施: Durvalumab (Drug)
Patients with SCLC
Patients with Small Cell Lung Cancer
干预措施: Cisplatin (Drug)
Patients with SCLC
Patients with Small Cell Lung Cancer
干预措施: Etoposide (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax)
时间窗: Approximately 16 months
Number of patients with injection site reactions and immune-mediated reactions
时间窗: Approximately 16 months
Observed serum concentration (Ctrough)
时间窗: Approximately 16 months
次要结局
- Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies(Approximately 16 months)
- Part 2 only: Overall Response Rate (ORR) - proportion of participants with a complete or partial response to treatment as determined using RECIST 1.1 guidelines(Approximately 16 months)
- Changes in WHO/ECOG performance status(Approximately 16 months)
- Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry(Approximately 16 months)
- Incidence of Adverse Events(Approximately 16 months)
- Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (respiration rate) in breaths per minute(Approximately 16 months)
- Time to maximum observed serum concentration (tmax) of durvalumab(Approximately 16 months)
- Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg)(Approximately 16 months)
- Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (pulse rate) in beats per minute(Approximately 16 months)
- Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab(Approximately 16 months)
- Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals(Approximately 16 months)
- Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius(Approximately 16 months)
- Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug(Approximately 16 months)
- Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology(Approximately 16 months)