CTIS2023-503920-14-00招募中1 期
A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, with Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer - BO42777
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 385
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Whole-body positron emission tomography/computed tomography scan (PET-CT) performed prior and within 42 days of the first dose of cCRT or sCRT, Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology (Version 8, American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system), No disease progression during or following receipt of at least 2 cycles of platinum-based cCRT or sCRT, Documented ALK fusion positivity (Cohort A1), Documented ROS1 fusion positivity (Cohort A2), Ability to swallow entrectinib intact, without chewing, crushing, or opening the capsules (Cohort A2)
排除标准
- •Any history of previous NSCLC and/or any history of prior treatment for NSCLC, Any evidence of Stage IV disease, NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene, as identified by site local testing or Sponsor central testing, Prior treatment with ALK inhibitors (Cohort A1), Prior treatment with ROS1 inhibitors (Cohort A2), Active or history of autoimmune disease or immune deficiency
研究者
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A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF PATIENTS SELECTED ACCORDING TO BIOMARKER STATUS, WITH LOCALLY ADVANCED, UNRESECTABLE, STAGE III NON-SMALL CELL LUNG CANCERNL-OMON53740Roche Nederland B.V.3