CTRI/2020/07/026870招募中2 期
A Phase IIb/III, Randomised, Double-blind, Placebo-controlled, Multicentre,Study of CA-170 in Combination with Chemotherapy and Radiation in Patients with Unresectable Stage III or IVa Non-Squamous Non-Small Cell Lung Cancer (ASIAD-2) - ASIAD-2
Aurigene Discovery Technologies Limited A Subsidiary of Dr Reddys Laboratories Limited India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1. Histologically confirmed unresectable (Stage III or IVa) Non-Squamous NSCLC
- •2. Newly diagnosed
- •3. Eligible for chemo-radio therapy as SOC
- •4. ECOG Status:0 or 1
- •5. Adequate organ and bone marrow functions
- •6. Willing to provide written informed consent and comply with trial requirements
排除标准
- •1. Mixed small cell and non-small cell lung cancer histology
- •2. Squamous histology or mixed squamous / non-squamous NSCLC histology
- •3. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- •4. Ongoing treatment for unresectable Stage III or IVa Non-Squamous NSCLC
- •5. Participation in another clinical study with an investigational product during the last 3 months
- •6. Recent major surgery within 4 weeks
- •7. Active or prior documented autoimmune disease within 2 years
- •8. Active or prior documented inflammatory bowel disease
- •9. History of primary immunodeficiency
- •10. History of organ transplant that requires therapeutic immunosuppression
- •11. Stage 1, Stage 2, Stage 4b or Stage 4c NSCLC.
- •12. Stage 4a NSCLC patients with clinically significant malignant pleural effusion and/or pericardial effusion, as judged by PI, and therefore, not candidates for combined chemoradiation.
- •13. Not eligible for combined chemoradiation, for any reason
- •14. Non Sq NSCLC with known positive EGFR or ALK or ROS1 mutations
- •15. Uncontrolled inter current illness
- •16. Known history of active tuberculosis within past 5 years
- •17. Receipt of live attenuated vaccination within 30 days prior to treatment period day 1
- •18. History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
- •19. Female patients who are pregnant, breast-feeding, or male or female patients of reproductive potential who do not agree for birth control
- •20. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
研究者
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