2024-515902-15-00招募中2 期
A Phase II, single-arm trial of Atezolizumab/Platinum/Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung (LCNEC-ALPINE)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 15
- 主要终点
- Overall Survival (OS, time to event endpoint, measured from cycle 1 day 1 (C1D1) to death from any cause)
研究概览
简要总结
The primary objective of this trial is to evaluate the efficacy of Atezolizumab in addition to standard of care (SoC) chemotherapy for the treatment of LCNEC as measured by overall survival (OS).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%)
- •Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment)
- •Planned treatment with Carboplatin or Cisplatin and Etoposide (standard of care - SoC)
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
- •age ≥18 years
- •measurable disease according to RECIST v1.1
- •adequate organ function defined as: Alanine Aminotransferase (ALAT) / Aspartate Aminotransferase (ASAT) ≤2.5x ULN or ≤3.5x Upper limit of Normal (ULN) in case of liver metastases; Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases; Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60 ml/min; Neutrophils ≥1 Gigaparticle (Gpt)/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis
排除标准
- •Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
- •Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
- •Severe uncontrolled infection
- •Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
- •Any prior treatment for metastatic disease
结局指标
主要结局
Overall Survival (OS, time to event endpoint, measured from cycle 1 day 1 (C1D1) to death from any cause)
Overall Survival (OS, time to event endpoint, measured from cycle 1 day 1 (C1D1) to death from any cause)
次要结局
- Objective response rate (ORR) defined as partial remission (PR) or complete remission (CR) according to RECIST v1.1
- Immune ORR (iORR) defined as immune PR (iPR) or immune CR (iCR) according to iRECIST
- Disease control rate (DCR) defined as combination of CR, PR and stable disease (SD) according to RECIST v1.1
- Progression free survival (PFS) defined as time from C1D1 to progression according to RECIST v1.1, or to start of any other anticancer treatment, or death from any cause whichever occurs first
- Immune PFS (iPFS) defined as time from C1D1 to progression according to iRECIST or death from any cause whichever occurs first
- Duration of response (DoR) defined as time from first documented PR or CR according to RECIST v1.1 to time of disease progression according to RECIST v1.1 or death from any cause whichever occurs first
- PFS/ iPFS (according to RECIST v1.1 and iRECIST) rate at 1 year
- OS rate at 1 year
- PFS, OS, DoR and ORR in central pathology confirmed cases of LCNEC
- Incidence, nature, severity of adverse events (grading according to NCI CTCAE (v5.0)
研究者
Prof. Dr. Martin Wermke
Scientific
Technische Universitaet Dresden
研究点 (15)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study of Atezolizumab in Patients with Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer who have already received chemotherapy and radiotherapyon-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code: 10029519Term: Non-small cell lung cancer stage III Class: 100000004864CTIS2023-503756-27-00F. Hoffmann-La Roche AG130
尚未招募
Unknown
A single-arm phase II trial of Atezolizumab and Bevacizumab with combined radiotherapy in advanced hepatocellular carcinoma with portal vein invasioKCT0008733Yonsei University Health System, Severance Hospital51
进行中（未招募）
2 期
A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the LungLarge Cell Neuroendocrine Carcinoma of the LungNCT05470595Technische Universität Dresden67
招募中
2 期
“A Phase II trial of atezolizumab plus CArboplatin plus nab-Paclitaxel as first-line Therapy in metastatic triple-negative PD-L1 positive breast cancer patients”2024-519514-31-00Consorzio Oncotech104
进行中（未招募）
1 期
Study to assess efficacy of Atezolizumab in combination with Carboplatin Plus Pemetrexed in patients who are chemotherapy-naïve and have stage IV non-squamous non-small cell lung cancer with asymptomatic brain metastases (ATEZO-BRAIN)Atezolizumab combined with carboplatin and pemetrexedMedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864EUCTR2017-005154-11-ESSpanish Lung Cancer Group (SLCG/GECP)40