EUCTR2014-002161-30-PT进行中（未招募）1 期
A multicenter, randomized, double-blind Phase III trial to evaluate efficacy and safety of BI 695502 plus chemotherapy versus Avastin® plus chemotherapy in patients with advanced nonsquamous 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
- 1,030
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
入选标准
- •- Aged =18 years (for Japan only: Age =20 years at Screening)
- •- Recurrent or metastatic disease (Stage IV) with an indication for therapy with paclitaxel + carboplatin + Avastin®
- •- Negative epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation status. Patients harboring tumors with unknown or positive EGFR or ALK mutation may be included, provided chemotherapy is the site standard-of-care for those patients. Despite EGFR/ALK mutational status, patients may enter the trial if the site's best standard of care would be to administer such a chemotherapy regimen for that specific patient. However, if an EGFR/ALK test result is pending, and chemotherapy treatment would be switched in case of a mutational positive result, patients may not be included in this trial.
- •-Patients must have at least one measurable lesion according to RECIST 1.1, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •- Life expectancy >6 months based on clinical judgment.
- •-Patients must have adequate hepatic, renal, and bone marrow function.
- •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 410
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 261
排除标准
- •- Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including Avastin®.
- •- Prior systemic therapy for metastatic disease ( Prior systemic therapy and/or radiotherapy for locally advanced disease permitted if completed >12 months prior to Screening) .
- •- Known symptomatic brain metastasis.
- •- Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung, NSCLC NS (not specified) or NSCLC NOS (not otherwise specified).
- •- Contraindication to bevacizumab
研究者
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