EUCTR2018-001517-32-IT进行中（未招募）1 期
A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 versus Pembrolizumab as a First-line Treatment in Patients with PD-L1 Expressing Advanced Non-small Cell Lung Cancer - 1L NSCLC Phase II RCT M7824 vs Pembrolizumab
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MERCK KGAA
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. = 18 years of age inclusive, at the time of signing the informed consent
- •2. histologically confirmed diagnosis of advanced NSCLC and:
- •a. Have not received prior systemic therapy treatment for their advanced/Stage IV NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
- •Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade = 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications.
- •b. Have measurable disease based on RECIST 1.1
- •c. Have a life expectancy of at least 3 months
- •d. Availability of either tumor archival material (< 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine
- •PD-L1 expression level prior to enrollment
- •e. PD-L1 high status is required
- •(other protocol defined criteria could apply)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. The participant's tumor harbors an EGFR sensitizing (activating) mutation, ALK
- •translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved
- •2. Has received major surgery within 4 weeks prior to the first dose of study intervention;
- •received thoracic RT of > 30 Gy within 6 months prior to the first dose of study
- •7. Known severe hypersensitivity reactions to mAB
- •8. Receipt of any organ transplantation
- •9. Has interstitial lung disease (ILD) OR has had a history of pneumonitis that has required
- •oral or IV steroids
- •10. Significant acute or chronic infections
- •11. Has a history or current evidence of any condition, therapy, or laboratory abnormality
- •that might confound the results of the study, interfere with participation for the full
- •duration of the study, or is not in the best interest of the participant, in the opinion of the
- •treating Investigator
- •12. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
- •anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) intervention.
- •13. Previous malignant disease
- •14. Has active CNS metastases causing clinical symptoms or metastases that require therapeutic intervention and/or carcinomatosis meningitis
- •15. Active autoimmune disease that has required systemic treatment in past 1 year OR is
- •receiving systemic steroid therapy < 3 days prior to the first dose of study intervention or
- •receiving any other form of immunosuppressive medication.
- •16. Is expected to require any other form of systemic or localized antineoplastic therapy
- •while on study (including maintenance therapy with another agent for NSCLC, RT,
- •and/or surgical resection) (other protocol defined criteria could apply)
研究者
相似试验
进行中（未招募）
1 期
1L NSCLC Phase II RCT M7824 vs PembrolizumabEUCTR2018-001517-32-GRMerck KGaA300
进行中（未招募）
1 期
1L NSCLC Phase II RCT M7824 vs Pembrolizumabon-small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001517-32-ESMerck KGaA300
招募中
1 期
A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial CancerCTIS2023-504027-78-00F. Hoffmann-La Roche AG244
进行中（未招募）
1 期
A Phase II, Multicenter, Randomized, Open-Label, Dose-Ranging, Parallel Group Study to Compare the Anti-Viral Effects, Pharmacokinetics and Safety of HepeX-B, a Mixture of Two Monoclonal Antibodies, as Compared to Hepatitis B Immune Globulin in Patients who have Received Hepatic Allografts for Treatment of End-Stage Liver Disease due to Hepatitis B Virus InfectioHepatic allograft recipients for treatment of hepatitis B virus infection.EUCTR2004-000501-21-GBXTL Biopharmaceuticals75
进行中（未招募）
1 期
A trial to learn how well REGN9933 works for preventing blood clots after knee replacement surgery in adult participantsCTIS2022-501470-18-00Regeneron Pharmaceuticals Inc.432