A Pilot Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be >18 years old at time of diagnosis
- •Histologically confirmed non-small cell lung cancer
- •Clinical staging of IIIc or IV disease.
- •4A. For patients with stage IIIc disease, patients are ineligible for or refuse standard treatment with platinum-double chemotherapy and radiation.
- •4B. For patients with stage IV disease, platinum doublet chemotherapy is not appropriate, deemed unsafe by the treating physician, or declined by the patient
- •4C. Screening lab work must meet the following parameters:
- •4Ca. Absolute neutrophil count (ANC) ≥1000/mm3
- •4Cb. Platelet count ≥100,000/mm3
- •4Cc. CrCl>50 (if pemetrexed is to be offered)
- •4Cd. AST and ALT ≤ 2.5 x ULN
- •4D. Patients with small, asymptomatic brain metastases are eligible
- •4E. Women of childbearing potential must be negative for pregnancy testing (urine or blood) and agree to use effective contraception. Viable contraception should be used after trial screening, before initiation of chemotherapy, and throughout the duration of active treatment in the study.
- •Non-childbearing potential is defined as (by other than medical reasons): -Amenorrheic >2 years
- •Amenorrheic for <2 years and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation
- •Post hysterectomy, oophorectomy or tubal ligation. Otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study drug
- •4F.Participants must read or be read and explained the purposes of the study and sign a statement of informed consent prior to participation. Those who do not read or understand English are eligible and may be consented according to institutional regulations.
排除标准
- •Patients with history of autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis
- •Patients on immunosuppressive medication, including steroids (if doses exceed equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to start of treatment are acceptable.
- •Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy and/or immunotherapy per the treating investigator.
- •The patient must not be on any clinical trials involving other experimental therapies during study treatment
- •Women who are currently pregnant or breast-feeding
- •Patients with any other concurrent medical or psychiatric condition that were deemed inappropriate for entry into the study per the investigator.
- •Symptomatic, untreated brain metastases. Patients with treated brain metastases may be considered eligible after completion of radiation if steroids have been tapered to less than equivalent of 10 mg of prednisone.
- •Active infection requiring IV antibiotics
研究组 & 干预措施
Experimental 1: pembrolizumab and Pemetrexed
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days
Pembrolizumab 200 mg and Pemetrexed 500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
干预措施: Pemetrexed (Chemotherapy) (Other)
Experimental 2: pembrolizumab and Nab-paclitaxel
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days
Pembrolizumab 200 mg and Nab-paclitaxel 100 mg/m2 days 1,8 of 21 day cycle x 4 cycles followed by pembrolizumab alone
干预措施: Nab-paclitaxel (Chemotherapy) (Other)
Experimental 1: pembrolizumab and Pemetrexed
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days
Pembrolizumab 200 mg and Pemetrexed 500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
干预措施: Pembrolizumab (Drug)
Experimental 2: pembrolizumab and Nab-paclitaxel
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days
Pembrolizumab 200 mg and Nab-paclitaxel 100 mg/m2 days 1,8 of 21 day cycle x 4 cycles followed by pembrolizumab alone
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Number of participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 18 Months
Determine the rate of treatment-limiting toxicities in patients with advanced non-small cell lung cancer with ECOG PS 2 who are treated with pembrolizumab and single-agent chemotherapy
次要结局
- Percentage of participants with Complete Response or Partial Response(18 Months)
研究者
Megan Baumgart
Assistant Professor
University of Rochester