A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS >=50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08) - TROPION-Lung08 Study (Daiichi DS1062-A-U304)

Daiichi Sankyo, Inc.0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 尚未招募
发起方: Daiichi Sankyo, Inc.
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

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. Sign and date the Tissue Screening and Main ICFs, prior to the start of any
•study-specific qualification procedures.
•2. Adults >=18 years or the minimum legal adult age (whichever is greater) at
•the time of informed consent. (Follow local regulatory requirements if the
•legal age of adult voluntary consent for study participation is >18 years old.)
•3. Histologically documented NSCLC that meets all of the following criteria:
•a. Stage IIIB or IIIC disease and not candidates for surgical resection or
•definitive chemoradiation, or Stage IV NSCLC disease at the time of
•randomization (based on the American Joint Committee on Cancer, Eighth
•Edition). Subjects with early-stage NSCLC who have relapsed should be restaged
•during screening to ensure their eligibility for the study.
•b. Documented negative test results for EGFR, ALK, and ROS1 actionable genomic
•alterations based on analysis of tumor tissue. If test results for EGFR, ALK,
•and ROS1 are not available, subjects are required to undergo testing performed
•locally for these genomic alterations.
•c. No known actionable genomic alterations in NTRK, BRAF, RET, MET, or other
•actionable driver kinases with locally approved therapies. (Testing for genomic
•alterations besides EGFR, ALK, and ROS1 is not required prior to
•randomization). Subjects with squamous NSCLC are only required to undergo EGFR,
•ALK, and ROS1 testing if they have no history of tobacco smoking or were
•diagnosed with NSCLC at <40 years of age. Subjects whose tumors harbor KRAS
•mutations are eligible for the study.
•4. Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4-micron
•sections or block equivalent) for the measurement of TROP2 protein expression
•and for the assessment of other exploratory biomarkers. This tissue requirement
•is in addition to the tissue required for PD-L1 testing for tissue screening
•purposes. If a documented law or regulation prohibits (or does not approve)
•sample collection, then such sample will not be collected.
•5. Tumor has high PD-L1 expression (TPS >=50%) as determined by PDL1 IHC 22C3
•pharmDx assay by central testing (minimum of 6 slides).
•6. Has an adequate treatment washout period before Cycle 1 Day 1 as defined in
•protocol Section 5.1.
•7. Measurable disease based on local imaging assessment using RECIST Version
•1.1 (see Section 10.4 of the protocol).
•8. Has left ventricular ejection fraction (LVEF) >=50% by either an
•echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days
•before randomization.
•9. ECOG PS of 0 or 1 at screening.
•10. Has a life expectancy of at least 3 months.
•11. Adequate bone marrow function within 7 days before randomization as defined
•in protocol Section 5.1.
•12. If the subject is a female of childbearing potential, she must not be
•pregnant, breastfeeding or intend to become pregnant during the study; she must
•also have a negative serum pregnancy test at screening and must be willing to
•use highly effective birth control (as detailed in protocol Section 10.3.4) or
•avoid heterosexual intercourse upon randomization, during the Treatment Period,
•for 7 months following the last dose of Dato-DXd, and for 4 months following
•the last dose of pembrolizumab, whichever occurs later. A female is considered
•of childbearing potential following menarche and until becoming postmeno

排除标准

•1. Has received prior systemic treatment for advanced or metastatic NSCLC.
•2. Has received prior treatment for NSCLC with any of the following, including
•in the adjuvant/neoadjuvant setting:
•a. Any agent, including an antibody-drug conjugate, containing a
•chemotherapeutic agent targeting topoisomerase I.
•b. TROP2-targeted therapy.
•c. Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti- PD-ligand
•2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory
•T-cell receptor (eg, CTLA-4, OX40, CD137).
•d. Any other immune checkpoint inhibitors. Subjects who received adjuvant or
•neoadjuvant therapy OTHER than those listed above, are eligible if the
•adjuvant/neoadjuvant therapy was completed at least 6 months prior to the
•diagnosis of advanced/metastatic disease.
•3. Has spinal cord compression or active and untreated central nervous system
•(CNS) metastases and/or carcinomatous meningitis. Subjects with previously
•treated brain metastases may participate provided they are radiologically
•stable (ie, without evidence of progression) for at least 2 weeks by repeat
•imaging (note: repeat imaging should be performed during study screening),
•clinically stable, and without requirement of steroid treatment for at least 7
•days before the first dose of study drug.
•Note: A computed tomography (CT) scan or magnetic resonance imaging (MRI) scan
•of the brain at baseline (MRI preferred) 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 4 weeks later (in
•which case, repeat of all screening activity may be required).
•4. Has received prior radiotherapy <=4 weeks of start of study intervention or
•more than 30Gy to the lung within 6 months of Cycle 1 Day 1. Subjects must have
•recovered from all radiation related toxicities, without requiring
•corticosteroids. A 2- week washout is permitted for palliative radiation to the
•non-thoracic region.
•5. History of another primary malignancy (beyond NSCLC) except for the
•- Malignancy treated with curative intent and with no known active disease >=3
•years before the first dose of study treatment and of low potential risk for
•- Adequately treated non-melanoma skin cancer or lentigo maligna without
•evidence of disease
•- Adequately treated carcinoma in situ without evidence of disease
•- Participants with a history of prostate cancer (tumor/node/metastasis stage)
•of Stage <=T2cN0M0 without biochemical recurrence or progression and who in the
•opinion of the investigator are not deemed to require active intervention.
•6. Has a history of (non-infectious) interstitial lung disease
•(ILD)/pneumonitisn including radiations pneumonitis that required steroids, has
•current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled
•out by imaging at screening.
•7. Clinically severe pulmonary compromise, as judged by the investigator,
•resulting from intercurrent pulmonary illnesses including, but not limited to,
•any underlying pulmonary disorder (eg, pulmonary emboli diagnosed within 3
•months of Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary
•disease, restrictive lung disease, pleural

研究者

发起方

Daiichi Sankyo, Inc.

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