EUCTR2018-001517-32-BE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 ExpressingAdvanced 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
- •[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)
- •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
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