EUCTR2018-001517-32-DE进行中（未招募）1 期
An Adaptive Phase III Multicenter, Randomized, Open-Label, Controlled Study of M7824 (bitrafusp alfa) versusPembrolizumab as a First-line Treatment in Patients with PD-L1 Expressing Advanced Non-small Cell Lung Cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 584
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 tumor tissue (< 6 months old, excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
- •e. PD-L1 high status by central testing 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 292
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 292
排除标准
- •1. Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved:
- •a. EGFR sensitizing (activating) mutation
- •b. ALK translocation(s) associated with responsiveness to ALK tyrosine kinase inhibitors
- •c. ROS1 rearrangement(s) associated with responsiveness to ROS1 tyrosine kinase inhibitors
- •d. BRAF V600E mutation
- •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 (Grade = 3 National Cancer Institute
- •[NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0) to
- •investigational product (M7824 or pembrolizumab) or any components in their
- •formulations, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma)
- •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. Participants with history of bleeding diathesis or recent major bleeding events considered by the Investigator as high risk for investigational drug treatment , such as patients with clinically relevant bleeding events of hemoptysis Grade = 2 within the last month, are also excluded.
- •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 co-stimulation or checkpoint pathways)
- •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
Clinical study phase III, first line treatment of patients with lung cancercomparing investigational drug M7824 vs Pembrolizumab.EUCTR2018-001517-32-BEMerck Healthcare KGaA584
已完成
3 期
An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (bintrafusp alfa) versus Pembrolizumab as a First-line Treatment in Patients with PD-L1 Expressing Advanced Non-small Cell Lung Cancer (MS200647-0037)10038666Non-small cell lung cancerlung cancerNL-OMON49475Merck34
进行中（未招募）
1 期
Clinical study phase III, first line treatment of patients with lung cancer comparing investigational drug M7824 vs Pembrolizumabon-small Cell Lung CancerMedDRA version: 21.1Level: 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-NLMerck Healthcare KGaA584
未知
3 期
A study of RO5304020 versus taxane in patients with advanced gastric cancerPatients who have HER2 -positive advanced gastric cancerJPRN-jRCT2080221881Chugai Pharmaceutical Co., Ltd.412
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of trastuzumab emtansine compared to a taxane (docetaxel or paclitaxel), in patients with previously treated gastric cancer that spread to other tissues, including adenocarcinoma of the gastroesophageal junction.Human Epidermal growth factor Receptor 2 (HER2) positive locally advanced or metastatic Gastric Cancer (GC), including adenocarcinoma of the gastroesophageal junction (GEJ).MedDRA version: 14.1Level: LLTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-000660-22-ESF. Hoffmann?La Roche Ltd412