EUCTR2017-002672-38-ES
进行中（未招募）
1 期
Open-Label, Randomized Trial of Nivolumab (BMS-936558) plus Pemetrexed/Platinum or Nivolumab plus Ipilimumab (BMS-734016) vs Pemetrexed plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects with Epidermal Growth Factor Receptor (EGFR) Mutation, T790M Negative Who Failed 1L EGFR Tyrosine Kinase Inhibitor Therapy - CheckMate 722: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 722
适应症Subjects with EGFR mutation, T790M negative NSCLC who failed first line (1L) EGFR TKI therapyMedDRA version: 20.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Subjects with EGFR mutation, T790M negative NSCLC who failed first line (1L) EGFR TKI therapy
- 发起方
- Bristol-Myers Squibb International Corporation
- 入组人数
- 465
- 状态
- 进行中（未招募）
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Signed Written Informed Consent
- •2\. Target Population
- •a) Eastern Cooperative Group (ECOG) Performance Status 0\-1
- •b) Subjects with histologically confirmed Stage IV or recurrent EGFR MT\+ (ie, G719X,
- •L861Q, Del 19, and L858R) NSCLC (per the 7th International Association for the Study
- •of Lung Cancer classification)37 with disease progression on therapy with 1 prior EGFR
- •TKI therapy consisting of erlotinib, afatinib, or gefitinib
- •c) No evidence of exon 20 T790M mutation detected by tumor or cfDNA analysis obtained
- •at progression on prior EGFR TKI therapy. T790M testing will be confirmed centrally
- •using the cobas® EGFR Mutation Test v2 (US\-IVD).
排除标准
- •1\. Target Disease Exceptions
- •a) Subjects with known EGFR mutation, T790M positive, detected by tumor or cfDNA
- •b) Subjects with known ALK translocations which are sensitive to available targeted
- •inhibitor therapy are excluded. If tested, use of an FDA\-approved test is strongly
- •encouraged. Subjects with unknown or indeterminate ALK status may be enrolled.
- •d) Subjects with carcinomatous meningitis
- •f) Subjects with known SCLC transformation
- •g) Subjects who have progressed within 3 months of 1L EGFR TKI.
- •2\. Medical History and Concurrent Diseases
- •a) Subjects must have recovered from the effects of major surgery or significant traumatic
结局指标
主要结局
未指定
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