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) - DS1062-A-U304

Daiichi Sankyo Inc.0 个研究点目标入组 738 人开始时间: 2024年2月27日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Daiichi Sankyo Inc.
入组人数: 738

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 65+（—）
性别: All

入选标准

•Sign and date the Tissue Screening and Main ICFs, prior to the start of any study-specific qualification procedures., Has a life expectancy of at least 3 months., Adequate bone marrow function within 7 days before randomization as defined in protocol Section 5.1., 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 postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)., If male, the subject must be surgically sterile or must use a condom in addition to their partner using a highly effective birth control (Section 10.3.4 of the protocol) if their partner is of reproductive potential or avoid heterosexual intercourse upon enrollment, during the Treatment Period, and for 4 months following the last dose of Dato-DXd., Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the last dose of Dato-DXd. Preservation of sperm should be considered prior to enrollment in this study., Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the last dose of Dato-DXd, or for at least 4 months after the last dose of pembrolizumab, whichever occurs later. Preservation of ova should be considered prior to enrollment in this study., Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions., 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., 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

排除标准

•Has received prior systemic treatment for advanced or metastatic NSCLC., 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., 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), Has received prior radiotherapy =4 weeks of start of study intervention or more than 30 Gy 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, History of another primary malignancy (beyond NSCLC) except for the following: - 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 recurrence - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Adequately treated carcinoma in situ without evidence of disease - Subjects 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., Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening., 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 effusion, etc.), or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), or prior complete pneumonectomy., Uncontro

研究者

发起方

Daiichi Sankyo Inc.

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