NCT04467723招募中1 期
CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Occurrence of Grade 3 toxicity
研究概览
简要总结
The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung cancer participants.
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
- •Participant or legal representative is able to provide written informed prior to performing any protocol-related procedures
- •Is willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study
- •Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer
- •Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year
- •Life expectancy of at least 6 months
- •De novo stage IV or recurrent NSCLC without actionable mutation (e.g. EGFR/ ALK/ ROS-1) that was previously treated with either PD-1 / PD-L1 or the combination of PD1/PDL1 and cytotoxic chemotherapy, no more than 2 systemic regimens for metastatic disease with measurable disease *. Maintenance therapy will be considered part of the 1 regimen
- •At least 1 measurable lesion
- •PDL1 TPS score less than 1% or unknown: first-line must be PD1/PDL1 inhibitor in combination with chemotherapy
- •Early stage (I-III) NSCLC treated with adjuvant or neoadjuvant chemotherapy then PD1/PDL1 inhibitor treatment for recurrent disease
- •Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease
- •Eastern Cooperative Group (ECOG) Performance Status 0 - 2
- •Is able to swallow oral medications
- •Adequate hematologic function
- •Adequate organ function
排除标准
- •The presence of any other concurrent severe and/or uncontrolled medical condition that would, in the investigator or treating physician's judgement, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol
- •Has received investigational agents within 14 days or 5 half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment
- •Has a known hypersensitivity to atezolizumab or pirfenidone
- •Has active medical or psychiatric illness that would interfere with the study treatment
- •Has uncontrolled diabetes
- •Has any of the following cardiac diagnoses:
- •Unstable angina Myocardial infarction within 6 months Uncontrolled congestive heart failure Left ventricular ejection fraction < 35%
- •Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment
- •Is pregnant or breast feeding
- •Uncontrolled HIV
- •Clinically diagnosed with grade 2 or 3 radiation-induced lung injury within the last 3 months prior to registering for the study
- •Has a history of idiopathic pneumonitis that required systemic agent including steroid
- •Has drug-induced pneumonitis
- •Has evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •Smoker of more than 1 pack / day
- •Has active peptic ulcer diagnosed within 4 weeks of enrollment
- •Active infection requiring systemic treatment
- •Current use of systemic antibacterial or antifungal agent
- •Prior monoclonal antibody within 4 weeks before study Day 1 Exception: The use of denosumab
- •Patient not recovered to ≤ Grade 1 from AEs due to agents administered more than 4 weeks earlier
- •Concurrent use of other investigational agents
- •Uncontrolled or symptomatic brain metastasis or leptomeningeal disease that requires use of steroids
- •Use of strong CYP1A2 inhibitors
- •Previous history of cancer with active treatment within less than 1 year of enrollment
- •Active auto-immune diseases
研究组 & 干预措施
Treatment
Experimental
Atezolizumab (Tecentriq) intravenous (IV) 1200mg flat dose day 1 then every 3 weeks.
Pirfenidone (Esbriet) orally (PO) with food according to this schedule:
Days 1-14: 267 milligrams (mg) orally three times per day (PO TID) Days 15-29: 534 mg PO TID Days 30 onward until progression: 801 mg PO TID
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Occurrence of Grade 3 toxicity
时间窗: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
CTCAE v5.0
Occurrence of Grade 4 toxicity
时间窗: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
CTCAE v5.0
次要结局
- Overall response rate (ORR) of participants(Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days))
- Progression Free Survival (PFS)(From Cycle 1 day 1 (Each cycle is 21 days) for up to 2 years after end of treatment)
- 1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1(Cycle 1 day 1 up to 1 year post-Cycle 1 day 1 (Each cycle is 21 days))
研究者
研究点 (2)
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