NL-OMON54233已完成2 期
A Phase 2, Multicenter, Randomized Study of Trastuzumab deruxtecan in Subjects With HER2-Mutated Metastatic Non-Small Cell Lung Cancer (NSCLC) [Destiny-Lung02] - Destiny-Lung02
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
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 99（—）
入选标准
- •1. Must have provided informed consent for study participation (see Section
- •10.1.2 of the protocol) before performance of any study-specific procedure or
- •2. Men or women >=18 years old. (Please follow local regulatory requirements if
- •the legal age of
- •consent for study participation is >18 years old).
- •3. Pathologically documented metastatic NSCLC with a known activating HER2
- •(please refer to the list of HER2 mutations, see Table 10.2 of the protocol).
- •The HER2 mutation must be documented from an archival or fresh tumor tissue
- •sample analyzed by Clinical Laboratory
- •Improvement Amendments (CLIA) certified laboratory or equivalent laboratory
- •testing to Good Laboratory Practice (GLP) standard.
- •Note: HER2 mutation documented only from a liquid biopsy sample cannot be used
- •enrollment.
- •4. Subjects who had previous treatment including platinum therapy in the
- •metastatic/locally advanced setting and not amenable to curative surgery or
- •radiation. The subject must have progressed during or after the last treatment
- •regimen or discontinued because of unacceptable toxicity.
- •5. Presence of at least 1 measurable lesion confirmed by BICR based on RECIST
- •version 1.1.
- •6. Is willing and able to provide an adequate archival tumor tissue sample. A
- •fresh biopsy is
- •required if an archival tumor tissue sample cannot be supplied. Resection and
- •core needle biopsy are acceptable. Other tissue samples, eg, fine needle
- •aspirates or cell block are not
- •acceptable. For detailed instruction on tissue submission, please refer to the
- •laboratory manual.
- •7. Has ECOG PS of 0 to 1.
- •8. Has left ventricular ejection fraction (LVEF) >= 50% within 28 days before
- •randomization.
- •9. Has adequate organ function within 14 days before randomization (please
- •refer to additional information in the protocol, paragraph 5.1).
- •10. Has adequate treatment washout period before randomization (please refer to
- •additional information in the protocol, paragraph 5.1)
- •11. Male and female subjects of reproductive/childbearing potential must agree
- •to use a highly
- •effective form of contraception or avoid intercourse during and upon completion
- •of the study
- •and for at least 7 months for females and 4 months for males, after the last
- •dose of study drug.
- •Methods considered as highly effective methods of contraception are described
- •in Section 5.1 of the protocol.
- •12. Male subjects must not freeze or donate sperm starting at randomization and
- •throughout the study period, and at least 4 months after the final study drug
- •administration. Preservation of sperm
- •should be considered prior to randomization in this study.
- •13. Female subjects must not donate, or retrieve for their own use, ova from
- •the time of randomization and throughout the study treatment period, and for at
- •least 7 months after the final study drug administration. Female subjects must
- •refrain from breastfeeding throughout this time. Preservation of ova may be
- •considered prior to randomization in this study.
- 另有 2 项未显示
排除标准
- •Has a known driver mutation in the epidermal growth factor receptor (EGFR),
- •BRAF or MET exon 14 gene or a known anaplastic lymphoma kinase (ALK), ROS1, RET
- •or NTRK fusion.
- •2. Medical history of myocardial infarction within 6 months before
- •randomization, symptomatic
- •congestive heart failure (CHF) (New York Heart Association Class II to IV.
- •Subjects with
- •troponin levels above ULN at screening (as defined by the manufacturer), and
- •without any MI
- •related symptoms should have a cardiologic consultation before randomization to
- •rule out MI.
- •3. Has a corrected QT interval (QTcF) prolongation > 470 msec (females) or >450
- •msec (males)
- •based on average of triplicate12-lead ECG at screening.
- •4. 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
- •5. 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
- •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 brain radiotherapy and study
- •randomization.
- •6. Has multiple primary malignancies within 3 years, except adequately resected
- •non-melanoma
- •skin cancer, curatively treated in-situ disease, or other solid tumors
- •curatively treated.
- •7. Has a history of severe hypersensitivity reactions to either the drug
- •substances or inactive
- •ingredients in the drug product.
- •8. Has a history of severe hypersensitivity reactions to other monoclonal
- •antibodies.
- •9. Has an uncontrolled infection requiring intravenous (IV) antibiotics,
- •antivirals, or antifungals.
- •10. Has substance abuse or any other medical conditions such as clinically
- •significant cardiac or
- •psychological conditions, that may, in the opinion of the investigator,
- •interfere with the
- •subject*s participation in the clinical study or evaluation of the clinical
- •study results.
- •11. Known human immunodeficiency virus (HIV) infection. Subjects should be
- •tested for HIV
- •prior to randomization if required by local regulations or institutional review
- 另有 14 项未显示
研究者
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