NL-OMON49475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) - INTR@PID Lung 037 (MS200647-0037)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Merck
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy,
- •and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as
- •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
- •e. PD-L1 high status by central testing is required
- •(other protocol defined criteria could apply)
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
- •c. ROS1 rearrangement(s) associated with responsiveness to ROS1 tyrosine kinase
- •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 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
- •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
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