NCT03379441Unknown2 期
A Randomized Phase II Study of Pembrolizumab (MK-3475) as Maintainance Therapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer Treated With Definitive Chemo-radiotherapy
University of Turin, Italy14 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 126
- 试验地点
- 14
- 主要终点
- OS
研究概览
简要总结
Maintainance therapy in patients with unresectable stage III, NSCLC Stage IIIA-B, unresectable, NSCLC, treated with definitive Chemo-Radiotherapy
详细描述
This is an Italian multi-center randomized phase II trial (randomization 2:1) of intravenous (IV) MK-3475 (Pembrolizumab) versus observation as a maintenance therapy after chemo-radiotherapy (either concomitant or sequential, regardless of the type of chemotherapy used) in unresectable stage IIIA-IIIB non small cell lung cancer (NSCLC) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide written informed consent/assent for the trial.
- •Be > 18 years of age on day of signing informed consent.
- •Have measurable disease based on RECIST 1.
- •Be willing to provide tissue from a newly obtained core, trucut biopsy or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day
- •Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the PI.
- •Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation.
- •Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Section 8.14.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- •Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
排除标准
- •Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •Has a known history of active Bacillus Tuberculosis (TB)
- •Hypersensitivity to pembrolizumab or any of its excipients.
- •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or has evidence of interstitial lung disease.
- •Has an active infection requiring systemic therapy.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •Has known active Hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or Hepatitis C (e.g., HCV ribonucleic acid [RNA] qualitative is detected).
- •Has received a live vaccine within 30 days of planned start of study therapy.
研究组 & 干预措施
Experimental
Experimental
Pembrolizumab 200 mg Q3W IV infusion Day 1 of each 3 week cycle until:
- PD,
- unacceptable toxicity,
- investigator choice,
- patients IC withdrawal,
- up to a maximum of 24 months (35 administrations) Experimental
干预措施: Pembrolizumab Injectable Product (Drug)
结局指标
主要结局
OS
时间窗: up to 24 months per patient
The primary objective is to evaluate if treatment with chemo-radiotherapy followed by Pembrolizumab (MK-3475) maintenance (up to 24 months) results in superior Overall Survival (OS) in stage IIIA-B, unresectable, NSCLC compared to chemo-radiotherapy (CT-RT) followed by observation
次要结局
- PFS(up to 24 months per patient)
研究者
Prof. Silvia Novello
Principal Investigator
University of Turin, Italy
研究点 (14)
Loading locations...
相似试验
招募中
3 期
Phase III study of Pembrolizumab versus Pembrolizumab plus Carboplatin plus Pemetrexed for non-Sq NSCLC with PD-L1 50% or morenon-squamous non-small cell lung cancernon-squamous non-small cell lung cancer, pembrolizumab, PD-L1, carboplatin, pemetrexedJPRN-jRCTs031200078Kogure Yoshihito290
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab with Maintenance Olaparib or Maintenance Pemetrexed in 1L Metastatic Nonsquamous NSCLCCTIS2023-509774-40-00Merck Sharp & Dohme LLC672
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in 1L ES SCLCExtensive Stage Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004843-22-CZMerck Sharp & Dohme Corp.699
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in First-Line Metastatic Squamous NSCLCMetastatic Squamous Non-small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864EUCTR2018-004721-88-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.735
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in 1L ES SCLCExtensive Stage Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004843-22-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc699