A Phase II Trial of Pembrolizumab in Patients With Non-small Cell Lung Cancer and a Performance Status of 2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 10
- 主要终点
- Toxicity Rate
研究概览
简要总结
This study is to determine that pembrolizumab is safe and tolerable at the selected dose for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a performance status of 2. All patients will receive pembrolizumab.
详细描述
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. There are several studies which demonstrate a role for the immune system in fighting lung cancer. However, there are multiple mechanisms by which cancer dampens this response. The PD-1 receptor-ligand interaction is one of the major pathways hijacked by tumours to help evade detection and elimination by the cells of the immune system. A number of compounds which block this pathway, including the drug pembrolizumab, have shown impressive results in some patients.
At present all of the trials with pembrolizumab reported thus far have been in patients with a good Performance Status (PS) of 0-1, a measure of daily activity. Unfortunately many patients with lung cancer have impaired performance status, making them ineligible for trials of new therapies including anti PD-1. Clinical trials of standard-of-care therapy have been successfully performed in the PS=2 only population demonstrating the feasibility of performing clinical trials in this population.
In this trial, the investigators would like to determine whether this drug can be used to treat Performance status 2 patients with a lower general daily activity. The purpose of this trial is to determine that pembrolizumab is safe and tolerable. The investigators would also like to see how well the treatment works, find out more information about tumour shrinkage, and learn more about the disease and how it changes over time.
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 confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab.
- •Eastern Cooperative Oncology Group (ECOG) performance status
- •Life expectancy > 12 weeks.
- •Uni-dimensionally measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
- •Computerised Tomography (CT) scan of chest and abdomen within 28 days of starting pembrolizumab.
- •Adequate haematological function:
- •Platelet count ≥100 x 109 /L.
- •Neutrophils ≥1.5 x 109/L.
- •Haemoglobin ≥ 90 g/L.
- •Adequate hepatic function:
- •Serum bilirubin ≤1.5 x upper limit of normal (ULN).
- •Serum transaminases ≤2.5 x ULN.
- •Adequate renal function: Creatinine clearance <1.5 times ULN concurrent with creatinine clearance >50 ml/min.
- •Provision of signed and dated, written informed consent prior to any trial specific procedures, sampling and analyses.
排除标准
- •Patients who do not meet the criteria of performance status = 2 on the ECOG Performance scale.
- •Untreated symptomatic brain or leptomeningeal metastatic disease.
- •Medical or psychiatric conditions compromising informed consent.
- •Any medical condition which in the opinion of the investigator would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol.
- •Radiotherapy within 28 days of trial treatment.
- •Active autoimmune disease that has required systemic treatment in past 2 years
- •Chronic usage of steroids or other immunosuppressant medication.
- •Previous history of pneumonitis.
- •Any evidence of clinical autoimmunity.
研究组 & 干预措施
Pembrolizumab
Pembrolizumab: 200 mg Q3W, intravenous administration for a maximum of 2 years, or until progression or unacceptable toxicity.
干预措施: pembrolizumab (Drug)
结局指标
主要结局
Toxicity Rate
时间窗: Date of patient registration until 6 months after the administration of the last treatment (a maximum of 2 years treatment and 6 months followup after end of treatment)
Adverse events will be recorded in relation to each cycle of treatment and graded according to CTCAE criteria. The toxicity co-primary outcome measure for the trial is defined as the occurrence of a treatment-related dose delay or treatment discontinuation due to toxicity.
Durable Clinical Benefit
时间窗: ≥18 weeks, up to maximum of 2 years
Patients will have CT scans every 9 weeks from baseline until disease progression. On each occasion, overall tumour burden will be assessed using RECIST version 1.1. The efficacy co-primary outcome measure for the trial is durable clinical benefit defined as the occurrence of CR, PR or SD without prior progressive disease at or after the second scheduled CT scan (scheduled to occur at 18 weeks).
次要结局
- Health Related Quality of Life(Through study completion, up to a maximum of 2 years)
- Progression-free Survival Time(Progression-free survival time up to 2 years)
- Duration of Stable Disease(Survival time up to 2 years or date of death)
- Objective Response(≥18 weeks, up to maximum of 2 years)
- Time to Progression(Time to progression up to 2 years)
- Overall Survival Time(Survival time up to 2 years or date of death)
- Duration of Objective Response(Survival time up to 2 years or date of death)