JPRN-jRCT2031220277招募中1 期
A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer
Tagashira Shuzo0 个研究点目标入组 340 人开始时间: 2022年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 340
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- •2. Age greater than or equal to 18 years old at the same time of signing the informed consent.
- •3. Histologically or cytologically confirmed Extended Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
- •4. Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
- •5. Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- •6. Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
- •7. Adequate organ function as defined in protocol.
排除标准
- •1. History of other malignancy within the past 2 years with exceptions.
- •2. Major surgery within 28 days of study day 1.
- •3. Untreated or symptomatic brain metastases and leptomeningeal disease.
- •4. Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
- •5. History of immune-related colitis.
- •6. History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •7. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- •8. History of solid organ transplantation.
- •9. History of hypophysitis or pituitary dysfunction.
- •10. History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •11. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
研究者
相似试验
进行中（未招募）
1 期
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)Small Cell Lung CancerJPRN-jRCT2031220086Tagashira Shuzo50
尚未招募
不适用
A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancerlung cancerNL-OMON53561Amgen4
已完成
2 期
Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer1003859410036958Prostate CancerNL-OMON33942Amgen10
招募中
1 期
A Phase I Study to Evaluate the Safety and Efficacy of Mesenchymal Stromal Cells (MSC) for Treating Chronic Obstructive Pulmonary Disease (COPD)COPDRespiratory - Chronic obstructive pulmonary diseaseACTRN12614000731695Royal Perth Hospital10
进行中（未招募）
2 期
The Safety and Efficacy of THVD-102, a combination of Oxybutynin and Pilocarpine, in Subjects with Primary Focal Hyperhidrosis.ACTRN12615000873527TheraVida, Inc21