NL-OMON50493已完成3 期
A Phase III, Randomized, Multicenter, Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients with Extensive Disease Small-Cell Lung Cancer (SCLC) - Caspian
Astra Zeneca0 个研究点目标入组 19 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
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
- •-Male or female >=18 years at the time of Screening.
- •-Written informed consent and any locally required authorization obtained from
- •the patient/legal representative prior to performing any protocol-related
- •procedures, including screening evaluations.
- •-Histologically or cytologically documented extensive disease (American Joint
- •Committee on Cancer Stage (7th edition) IV SCLC [T any, N any, M1 a/b]), or T3-
- •4 due to multiple lung nodules that are too extensive or have tumor/nodal
- •volume that is too large to be encompassed in a tolerable radiation plan.
- •-Patients must be considered suitable to receive a platinum based chemotherapy
- •regimen as 1st line treatment for the ED-SCLC. Chemotherapy must contain either
- •cisplatin or carboplatin in combination with etoposide.
- •-Life expectancy >=12 weeks at Day 1.
- •-World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)
- •Performance Status of 0 or 1 at enrollment
- •-At least 1 lesion, not previously irradiated, that can be accurately measured
- •at baseline as >=10 mm in the longest diameter (except lymph nodes which must
- •have a short axis >=15 mm) with computed tomography (CT) or magnetic resonance
- •imaging (MRI) and that is suitable for accurate repeated measurements as per
- •RECIST 1.1 guidelines.
- •-No prior exposure to immune-mediated therapy including, but not limited to,
- •other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand
- •2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
- •- Adequate organ and marrow function
排除标准
- •- Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site).
- •- Previous IP assignment in the present study.
- •- Concurrent enrollment in another clinical study, unless it is an
- •observational (non-interventional) clinical study or during the follow-up
- •period of an interventional study.
- •- Participation in another clinical study with an IP during the last 4 weeks.
- •- Medical contraindication to etoposide-platinum (carboplatin or
- •cisplatin)-based chemotherapy
- •- Any history of radiotherapy to the chest prior to systemic therapy or planned
- •consolidation chest radiation therapy.
- •- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
- •- Major surgical procedure (as defined by the investigator) within 28 days
- •prior to the first dose of IP.
- •- History of allogenic organ transplantation.
- •- Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic
- •treatment (systemic steroids or immunosuppressive agents) or has a clinical
- •symptomatology suggesting worsening of PNS.
- •- Active or prior documented autoimmune or inflammatory disorders
- •- Uncontrolled intercurrent illness.
- •- History of another primary malignancy
- •- History of leptomeningeal carcinomatosis.
- •- History of active primary immunodeficiency.
- •- Active infection including tuberculosis, hepatitis B, hepatitis C, or human
- •immunodeficiency virus (positive HIV 1/2 antibodies).
- •- Current or prior use of immunosuppressive medication within 14 days before
- •the first dose of durvalumab or tremelimumab.
- •- Receipt of live, attenuated vaccine within 30 days prior to the first dose of
- •- Female patients who are pregnant or breastfeeding or male or female patients
- •of reproductive potential who are not willing to employ effective birth control
- •from Screening to 90 days after the last dose of durvalumab monotherapy or 180
- •days after the last dose of durvalumab + tremelimumab combination therapy.
- •- Known allergy or hypersensitivity to durvalumab, tremelimumab, etoposide,
- •carboplatin, cisplatin, or any of their excipients
- •- Prior randomization or treatment in a previous durvalumab and/or tremelimumab
- •clinical study regardless of treatment arm assignment.
研究者
相似试验
进行中（未招募）
1 期
A phase III, open-label, multiarm study to assess the efficacy of immunotherapy together with standard of care in patients diagnosed with extensive stage Small-Cell Lung CancerFirst-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001203-23-SKAstraZeneca AB984
进行中（未招募）
1 期
A phase III, open-label, multiarm study to assess the efficacy of immunotherapy together with standard of care in patients diagnosed with extensive stage Small-Cell Lung CancerFirst-line patients with extensive disease small-cell lung cancer (SCLC)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001203-23-BGAstraZeneca AB984
进行中（未招募）
1 期
A phase III, open-label, multiarm study to assess the efficacy of immunotherapy together with standard of care in patients diagnosed with extensive stage Small-Cell Lung CancerFirst-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC)MedDRA version: 20.0Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001203-23-CZAstraZeneca AB984
进行中（未招募）
1 期
A phase III, open-label, multiarm study to assess the efficacy of immunotherapy together with standard of care in patients diagnosed with extensive stage Small-Cell Lung CancerFirst-line patients with extensive disease small-cell lung cancer (SCLC)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001203-23-HUAstraZeneca AB984
进行中（未招募）
1 期
A phase III, open-label, multiarm study to assess the efficacy of immunotherapy together with standard of care in patients diagnosed with extensive stage Small-Cell Lung CancerEUCTR2016-001203-23-DEAstraZeneca AB984