PER-053-23尚未招募3 期
A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50%
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)0 个研究点目标入组 0 人开始时间: 2024年6月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
- 性别
- All
入选标准
- •Additional Categories: A life expectancy of at least 3 months.
- •Type of Participant and Disease Characteristics: Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c, AJCC Staging Manual, version 8).
- •Note: Mixed tumors will be characterized by the predominant cell type (squamous or nonsquamous); however, small cell elements are not permitted.
- •Type of Participant and Disease Characteristics: Confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R] AND absence of ALK and ROS1 gene rearrangements).
- •Note: If participant’s tumor has a predominantly squamous histology, molecular testing for EGFR mutation and ALK and ROS1 translocations is not required.
- •Note: The presence of a KRAS mutation in a participant’s tumor is permitted.
- •Note: Due to insufficient sensitivity, negative ctDNA results for EGFR, ALK, and ROS1 cannot be used to satisfy this inclusion criterion.
- •Type of Participant and Disease Characteristics: Has provided tumor tissue that demonstrates PD-L1 expression in =50% of tumor cells (TPS =50%) as assessed by IHC at a central laboratory.
- •Note: Assessment of PD-L1 expression must be made before randomization, from provided archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated. Tumor tissue from after diagnosis of metastatic disease is preferred. Details pertaining to tumor tissue submission can be found in the Laboratory Manual.
- •Demographics: Is an individual of any sex/gender, who is at least 18 years of age at the time of providing the informed consent.
- •Participants Assigned Male Sex at Birth:
- •If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. After the last dose of study intervention, the length of time required to continue contraception for each study intervention is:
- •- MK-2870: 100 days.
- •- Pembrolizumab: No contraception required for participants capable of producing sperm.
- •Refrains from donating sperm.
- •PLUS either:
- •Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent.
- •Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview) as detailed below:
- •- Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive method, as a condom may break or leak.
- •Note: Participants capable of producing
排除标准
- •Medical Conditions: Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- •Medical Conditions: Has Grade =2 peripheral neuropathy.
- •Medical Conditions: History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- •Medical Conditions: Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
- •Medical Conditions: Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
- •Prior/Concomitant Therapy: Received prior systemic anticancer therapy for their metastatic NSCLC.
- •Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- •Prior/Concomitant Therapy: Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- •Note: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- •Prior/Concomitant Therapy: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- •Prior/Concomitant Therapy: Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
- •Prior/Concomitant Therapy: Requires treatment with a strong inhibitor or inducer of CYP3A4 at least 14 days b
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