EUCTR2020-002774-27-IT进行中（未招募）1 期
Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced orMetastatic Non-small Cell Lung Cancer with Actionable Genomic Alterationsand Progressed on or After Kinase Inhibitor Therapy and Platinum-basedChemotherapy (TROPION-Lung05) - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •13. Has a left ventricular ejection fraction (LVEF) =50% by either an
- •ECHO or MUGA scan within 28 days before Cycle 1 Day 1.
- •14. Has adequate blood clotting function defined as international
- •normalized ratio/prothrombin time and either partial thromboplastin or
- •activated partial thromboplastin =1.5 × ULN.
- •15. Has an adequate treatment washout period before Cycle 1 Day 1
- •defined as:
- •-Major surgery: =3 weeks
- •-Radiation therapy including palliative radiation to chest =4 weeks
- •(palliative radiation therapy to other areas: =2 weeks)
- •-Anti-cancer chemotherapy (immunotherapy [non-antibody-based
- •therapy]), retinoid therapy: =2 weeks or 5 times the t1/2 of the
- •chemotherapeutic agent, whichever is longer; =6 weeks for nitrosoureas
- •or mitomycin C, =1 week for TKIs approved for the treatment of NSCLC -
- •baseline CT scan must be completed after discontinuation of TKI
- •-Antibody-based anti-cancer therapy: =4 weeks
- •-Chloroquine/Hydroxychloroquine: >14 days
- •16. Has a life expectancy =3 months based on investigator's opinion.
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has spinal cord compression or clinically active central nervous
- •system metastases, defined as untreated and symptomatic, or requiring
- •therapy with corticosteroids or anticonvulsants to control associated
- •symptoms. Subjects with clinically inactive brain metastases may be
- •included in the study. Subjects with treated brain metastases that are no
- •longer symptomatic and who require no treatment with corticosteroids
- •or anticonvulsants may be included in the study if they have recovered
- •from the acute toxic effect of radiotherapy. A minimum of 2 weeks must
- •have elapsed between the end of whole brain radiotherapy and study
- •enrollment.
- •Note: A CT or magnetic resonance imaging (MRI) scan of the brain at
- •baseline is required for all subjects. For those subjects in whom CNS
- •metastases are first discovered at the time of screening, the treating
- •investigator should consider delay of study treatment to document
- •stability of CNS metastases with repeat imaging at least 4 weeks later
- •(in which case, repeat of all screening activity may be required).
- •2. Has leptomeningeal carcinomatosis.
- •3. Prior treatment with:
- •a. An ADC containing a chemotherapeutic agent targeting topoisomerase I.
- •b. TROP2-targeted therapy.
- •4. Uncontrolled or significant cardiovascular disease, including:
- •a. Mean QT interval corrected for heart rate using Fridericia's formula
- •(QTcF) >470 milliseconds (msec) for females or >450 msec for males
- •(based on the average of screening triplicate 12-lead ECG
- •determinations).
- •b. History of myocardial infarction within 6 months prior to C1D1
- •c. History of uncontrolled angina pectoris within 6 months prior to C1D1
- •d. Symptomatic congestive heart failure (CHF) (New York Heart
- •Association Class II to IV) at screening. Subjects with a history of Class
- •II to IV CHF prior to screening, must have returned to class I CHF and
- •have LVEF =50% (by either an ECHO or MUGA scan within 28 days of
- •Cycle 1 Day 1) in order to be eligible.
- •e. History of serious cardiac arrhythmia requiring treatment.
- •f. LVEF <50% or institutional lower limit of normal by ECHO or MUGA
- •scan. within 28 days before Cycle 1 Day 1.
- •g. Uncontrolled hypertension (systolic >180
- •mmHg or diastolic >110 mmHg) within 28 days before C1D1
- •5. Has a history of (non-infectious) ILD/pneumonitis that required
- •steroids, has current ILD/pneumonitis, or where suspected
- •ILD/pneumonitis cannot be ruled out by imaging at screening.
- •6. Clinically severe pulmonary compromise resulting from intercurrent
- •pulmonary illnesses including, but not limited to, any underlying
- •pulmonary disorder (ie, pulmonary emboli within 3 months of the study
- •C1D1, severe asthma, severe chronic obstructive pulmonary
- •disease [COPD], restrictive lung disease, pleural effusion, etc.), or any
- •autoimmune, connective tissue or inflammatory disorders with
- •pulmonary involvement (ie, rheumatoid arthritis, Sjögren's syndrome,
- •sarcoidosis, etc.), or prior pneumonectomy.
- •7. Clinically significant corneal disease.
- •8. Uncontrolled infection requiring IV antibiotics, antivirals, or
- 另有 8 项未显示
研究者
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