EUCTR2015-003605-42-PT进行中（未招募）1 期
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN OR CISPLATIN+PEMETREXED COMPARED WITH CARBOPLATIN OR CISPLATIN+PEMETREXED IN PATIENTS WHO ARE CHEMOTHERAPY-NAIVE AND HAVE STAGE IV NON-SQUAMOUS 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
- 578
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
- •- Male or female, 18 years of age or older
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
- •- Patients with tumors of mixed non-small cell histology (i.e., squamous and non-squamous) are eligible if the major histological component appears to be non-squamous.
- •- No prior treatment for Stage IV non-squamous NSCLC
- •- Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy
- •- Measurable disease, as defined by RECIST v1.1
- •- Adequate hematologic and end organ function
- •- For patients enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan and of Chinese ancestry
- •- For enrollment into the China extension phase, residence in the People's Republic of China
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of ATZ or 6 months after the last dose of cisplatin, carboplatin, or pemetrexed. Women must refrain from donating eggs during this same period.
- •- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
- •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 374
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 306
排除标准
- •Cancer-Specific Exclusions
- •- Patients with a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
- •- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- •- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks prior to randomization
- •- Leptomeningeal disease
- •- Uncontrolled tumor-related pain
- •- Uncontrolled or symptomatic hypercalcemia (> 1.5 millimole/Liter ionized calcium or calcium > 12 milligram/deciliter or corrected serum calcium > upper limit of normal)
- •- Malignancies other than NSCLC within 5 years prior to randomization
- •- Known tumor PD-L1 expression status from other clinical studies
- •General Medical Exclusions:
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •- History of certain autoimmune disease
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- •- Severe infections within 4 weeks prior to randomization
- •- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- •Exclusion Criteria Related to Medications and Chemotherapy:
- •- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug prior to randomization
- •- Treatment with systemic immunosuppressive medications
- •Exclusion Criteria Related to Chemotherapy:
- •- History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
- •- Patients with hearing impairment (cisplatin)
- •- Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria (cisplatin)
- •- Creatinine clearance (CRCL) =< 60 milliliter (mL)/minute (min) for cisplatin or < 45 mL/min for carboplatin
研究者
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