CTIS2023-509644-10-00招募中1 期
A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer - XmAb717-06
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Xencor Inc.
- 入组人数
- 181
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 65+（—）
- 性别
- All
入选标准
- •Each subject must meet all of the following inclusion criteria to be enrolled in the study: 1. Able to provide written informed consent 2. Age = 18 years 3. Histologically confirmed, locally advanced (unresectable) or metastatic nonsquamous NSCLC 4. Documented absence of tumor activating EGFR mutation and ALK gene and c-ros oncogene 1 (ROS1) rearrangements. Patients with unknown or indeterminate EGFR, ALK, or ROS1 status are excluded 5. Documented absence of alterations in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies, based on testing conducted as part of standard local practice 6. PD-L1 IHC testing documenting TPS < 1% or between 1% and 49%, 7. No prior systemic treatment for advanced/metastatic NSCLC. Prior adjuvant, neoadjuvant, or chemoradiation/consolidation therapy is permitted, provided treatment was completed = 12 months prior to development of metastatic disease 8. Measurable disease by RECIST 1.1 (note: lesions in a previously irradiated site are measurable if progression has been demonstrated in those lesions) 9. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumor block(s)/slides 10. ECOG performance status score of 0 or 1 11. Life expectancy = 3 months, 12. Adequate organ function, as indicated by the following laboratory values • Hemoglobin = 9 g/dL, with no transfusion for = 4 weeks • Absolute neutrophil count = 1.5 × 109/L • Platelet count = 100 × 109/L • Alanine aminotransferase (ALT) < 3 × upper limit of normal (ULN) for subjects without liver metastases or < 5 × ULN for subjects with liver metastases • Total bilirubin = 1.5 × ULN, unless there is prior diagnosis and documentation of ongoing hemolysis or Gilbert’s syndrome • Thyroid stimulating hormone (TSH) within the normal range with or without replacement therapy (note, if TSH is not within the normal range, the patient may be eligible if reflex testing of total T3 or free T3 and free T4 are within the normal range) • Estimated creatinine clearance = 45 mL/min using the Cockcroft-Gault formula 13. Women of childbearing potential must agree to use a highly effective method of birth control and abstain from breastfeeding during the study, for 120 days after the last dose of vudalimab or pembrolizumab, and for 180 days after the last dose of chemotherapy • Women are considered to be of childbearing potential unless it is documented that they are over the age of 60, OR postmenopausal by history with no menses for 1 year and confirmed by follicle-stimulating hormone (using local reference ranges), OR have a history of hysterectomy and/or bilateral oophorectomy, OR have a history of bilateral tubal ligation • Highly effective methods of birth control include hormonal birth control (oral, intravaginal, or transdermal), or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or intrauterine), intrauterine devices (IUDs), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner (provided partner is the sole sexual partner and there has been a medical assessment of surgical success), or sexual abstinence, 14. Fertile male subjects must be willing to practice a highly effective method of birth control (ie, vasectomy or a condom in combination with double-barrier methods, spermicide, hormonal birth control, or an IUD [nonhormonal] used by the partner) and abstain from sperm donation during the study, for 120 days after the last dose
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study: 1. Participation in a study of an investigational agent or device within 4 weeks prior to planned start of study treatment 2. Expected to require any other anticancer therapy while on study 3. Major surgery within 3 weeks of planned start of study treatment 4. Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable (ie, are without evidence of progression for = 4 weeks by repeat imaging performed during the screening period, are clinically stable, and are without requirement of steroid treatment for = 7 days prior to the first dose of study treatment) 5. For patients treated in the neoadjuvant or adjuvant setting: • Failure to recover from any other cancer therapy-related toxicity (other than immune-related toxicity) related to previous anticancer treatment to = Grade 2 • History of a life-threatening (Grade 4) immune-mediated adverse event associated with prior administration of an immunotherapy agent • Failure to recover from any immunotherapy-related toxicity from prior cancer therapy to = Grade 1, except that subjects are eligible if a previous immunotherapy-related endocrinopathy is medically managed with hormone replacement therapy only or if immune-mediated alopecia has not resolved • Known history of severe hypersensitivity to monoclonal antibody therapy • Known history of hypersensitivity to platinum-based chemotherapy or pemetrexed 6. Active known or suspected autoimmune disease 7. Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted) 8. Receipt of an organ allograft, 9. Evidence of any serious bacterial, viral, parasitic, or systemic fungal infection within the 30 days prior to the first dose of study drug 10. Interstitial lung disease that is symptomatic or a history of pneumonitis requiring systemic glucocorticoid treatment. Lymphangitic spread of NSCLC is not an exclusion. 11. Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu and COVID-19 vaccines are permitted, as long as they do not contain live virus and are not administered within 24 hours of planned administration of study drug) 12. Known human immunodeficiency virus (HIV) positive with CD4+ T-cell (CD4+) count < 350 cells/µL, or an HIV viral load greater than 400 copies/mL, or a history of an acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, or not on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of study drug dosing. 13. Positive test for hepatitis C RNA 14. Positive test for hepatitis B surface antigen (hBsAg) or hepatitis B core antibody (hBcAb); a patient whose hBsAg is negative and hBcAb is positive may be enrolled if a hepatitis B virus (HBV) DNA test is negative and the subject is retested for HbsAg and HBV DNA every 2 months 15. History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than NSCLC, that, in the opin
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