EUCTR2017-001311-36-AT进行中（未招募）1 期
A Two-Part Randomized, Phase 3 Study of Combinations ofCemiplimab(Anti-PD-1 Antibody) and Platinum-based DoubletChemotherapy in First-line Treatment of Patients with Advanced orMetastatic 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
- 500
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. Men and women =18 years of age.
- •2. Patients with histologically or cytologically documented squamous or
- •non-squamous NSCLC with stage IIIB disease who are not candidates
- •for treatment with definitive concurrent chemoradiation or patients with
- •stage IV disease if they have not received prior systemic treatment for
- •recurrent or metastatic NSCLC.
- •3. Availability of an archival (=5 months) or on-study obtained formalinfixed,
- •paraffinembedded
- •tissue sample from a metastatic/recurrent site, which has not
- •irradiated.
- •Part 1 only: Expression of PD-L1 in <50% of tumor cells determined
- •the commercially available
- •assay performed by the central laboratory.
- •At least 1 radiographically measureable lesion by computed
- •resonance imaging (MRI) per RECIST 1.1 criteria. Target
- •may be located in a previously irradiated field if there is
- •(radiographic)
- •disease progression in that site.
- •ECOG performance status of =1.
- •Anticipated life expectancy of at least 3 months.
- •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 585
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •1. Part 1 only: Patients who have never smoked, defined as smoking =
- •100 cigarettes in a lifetime.
- •2. Active or untreated brain metastases or spinal cord compression.
- •Patients are eligible if
- •central nervous system (CNS) metastases are adequately treated and
- •patients have
- •neurologically returned to baseline (except for residual signs or
- •symptoms related to the
- •CNS treatment) for at least 2 weeks prior to enrollment. Patients must
- •(immunosuppressive doses of) corticosteroid therapy (see exclusion
- •criteria 7) for details
- •on timing of discontinuation of steroids).
- •3. Patients with tumors tested positive for EGFR gene mutations, ALK
- •gene translocations,
- •or ROS1 fusions. All patients will have tumor evaluated for EGFR
- •mutations, ALK
- •rearrangement, and ROS1 fusions.
- •4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to
- •informed consent.
- •5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis
- •or organizing
- •pneumonia), of active, noninfectious pneumonitis that required immunesuppressive
- •of glucocorticoids to assist with management, or of pneumonitis
- •years. A history of radiation pneumonitis in the radiation field is
- •pneumonitis
- •resolved =6months prior to enrollment.
- •Ongoing or recent evidence of significant autoimmune disease that
- •systemic immunosuppressive treatments, which may suggest risk
- •immune-related
- •treatment-emergent
- •adverse events (irTEAEs). The following are not
- •exclusionary:
- •childhood asthma that has resolved, residual hypothyroidism
- •required only
- •replacement, or psoriasis that does not require systemic
- •7. Patients with a condition requiring corticosteroid therapy (>10 mg
- •prednisone/day or
- •equivalent) within 14 days of randomization. Physiologic replacement
- •doses are allowed
- •even if they are >10 mg of prednisone/day or equivalent, as long as they
- •are not being
- •administered for immunosuppressive intent. Inhaled or topical steroids
- •are permitted,
- •provided that they are not for treatment of an autoimmune disorder.
研究者
相似试验
进行中（未招募）
1 期
A study of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in patients with lung canceron-Small Cell Lung CancerEUCTR2017-001311-36-PLRegeneron Pharmaceuticals, Inc.500
进行中（未招募）
1 期
A study of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in patients with lung canceron-Small Cell Lung CancerEUCTR2017-001311-36-RORegeneron Pharmaceuticals, Inc.500
进行中（未招募）
1 期
A study of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in patients with lung canceron-Small Cell Lung CancerEUCTR2017-001311-36-IERegeneron Pharmaceuticals, Inc.500
进行中（未招募）
1 期
A study of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in patients with lung canceron-Small Cell Lung CancerEUCTR2017-001311-36-GRRegeneron Pharmaceuticals, Inc.500
进行中（未招募）
1 期
A study of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in patients with lung cancerEUCTR2017-001311-36-LTRegeneron Pharmaceuticals, Inc.500