EUCTR2017-001311-36-IE进行中（未招募）1 期
A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab(Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with 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
- 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 or IIIC 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. The histologic diagnosis of NSCLC may be confirmed by a central laboratory.
- •3. Availability of an archival (=5 months) or on-study obtained formalin-fixed, paraffinembedded tumour tissue sample from a metastatic/recurrent site, which has not previously been irradiated.
- •4.Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by the commercially available assay performed by the central laboratory.
- •5. At least 1 radiographically measureable lesion by computed tomography (CT) or
- •magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target
- •lesions may be located in a previously irradiated field if there is documented
- •(radiographic) disease progression in that site.
- •6. ECOG performance status of =1.
- •7. 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 enrolment. Patients must be off (immunosuppressive doses of) corticosteroid therapy (see exclusion criteria 7) for details on timing of discontinuation of steroids).
- •3. Patients with tumours tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions. All patients will have tumour evaluated for EGFR mutations, ALK rearrangement, and ROS1 fusions confirmed by a central laboratory.
- •4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
- •5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organising
- •pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved =6months prior to enrolment.
- •6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
- •7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomisation. 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 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
进行中（未招募）
1 期
A study of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based DoubletChemotherapy in patients with lung canceron-Small Cell Lung CancerEUCTR2017-001311-36-ATRegeneron Pharmaceuticals, Inc.500