EUCTR2022-001440-18-FR进行中（未招募）1 期
A PHASE II, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, CONTROLLED STUDY OF RO7247669 PLUS PLATINUM-BASED CHEMOTHERAPY VERSUS PEMBROLIZUMAB PLUS PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- 性别
- All
入选标准
- •Age = 18 years
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Histologically or cytologically documented locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative surgery and/or definitive chemoradiotherapy (8th edition of the UICC/AJCC- staging system)
- •No prior systemic treatment for metastatic NSCLC
- •Known tumor PD-L1 status through a documented local assessment using a health authority-approved PD L1 immunohistochemistry assay
- •Confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded blocks or 15 unstained serial slides, along with an associated pathology report
- •Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- •Life expectancy = 12 weeks
- •Adequate hematologic and end-organ function
- •Negative human immunodeficiency viruses (HIV) test at screening
- •Negative hepatitis B surface antigen test at screening
- •Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by additional select criteria
- •Negative hepatitis C virus (HCV) antibody test at screening or positive HCV antibody test by a negative HCV RNA test at screening
- •Adequate cardiovascular function
- •For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of < 1% per year during the treatment period and for 4 months after the final dose of RO7247669, 4 months after the final dose of pembrolizumab, and 6 months after the final dose of platinum-based chemotherapy. Women must refrain from donating eggs during this same period
- •For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that together result in a failure rate of < 1% per year during the treatment period and for 4 months after the final dose of RO7247669 and 6 months after the final dose of pemetrexed, paclitaxel, and carboplatin. Men must refrain from donating sperm during this same period
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •NSCLC known to have a mutation in the epidermal growth factor receptor gene or an anaplastic lymphoma kinase fusion oncogene
- •Symptomatic, untreated, or actively progressing central nervous system metastases
- •Spinal cord compression not definitively treated with surgery and/or radiation
- •History of leptomeningeal disease
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Uncontrolled or symptomatic hypercalcemia
- •Active or history of autoimmune disease or immune deficiency
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
- •Active tuberculosis (TB)
- •Untreated latent TB
- •Current treatment with anti-viral therapy for hepatitis B virus (HBV) or HCV
- •Significant cardiovascular disease within 3 months prior to randomization
- •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •History of malignancy other than NSCLC within 5 years prior to randomization
- •Severe infection within 4 weeks prior to initiation of study treatment
- •Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- •Prior allogeneic stem cell or solid organ transplantation
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
- •Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •Any anti-cancer therapy, including hormonal therapy, within 21 days prior to initiation of study treatment
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- •Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment
- •Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies, fusion proteins, or platinum-containing compounds
- •Known hypersensitivity to Chinese hamster ovary cell products or to any component of the RO7247669 or pembrolizumab formulation
- •Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the patient may receive during the study
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study, within 4 months after the final dose of RO7247669 and pembrolizumab, or 6 months after the final dose of paclitaxel, pemetrexed or carboplatin
- ••Known targetable c-ROS oncogene 1 (ROS1), BRAFV600E or rearranged during transfection (RET) proto-oncogene genomic aberrations
研究者
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