A RANDOMIZED, PHASE 2, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY OF DOSTARLIMAB PLUS CHEMOTHERAPY VERSUS PEMBROLIZUMAB PLUS CHEMOTHERAPY IN METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER - 213403

Glaxosmithkline Research & Development Limited0 个研究点目标入组 242 人开始时间: 2023年11月30日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Glaxosmithkline Research & Development Limited
入组人数: 242

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 clinical trial of medicinal product

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Participant must be =18 years old, must be able to understand the study procedures, and agrees to participate in the study by providing written informed consent (as described in Appendix 4), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol., Participant has histologically- or cytologically-confirmed metastatic non-squamous NSCLC with documented absence of a sensitizing EGFR, ALK, ROS-1, or BRAF V600E mutation or other genomic aberration for which an approved targeted therapy is available. Mixed tumors will be categorized by the predominant cell type; if the tumor has predominantly squamous cell histology or if small cell elements are present, the participant is ineligible, Participants must have measurable disease, i.e., presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Measurable lesions situated in a previously irradiated area may be considered target lesions if progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible. See Appendix 1 for the definition of a measurable lesion., Participant has documented PD-L1 status by the 22C3 pharmDx assay (Agilent/Dako). If no prior PD-L1 result is available at the time of Screening, the participant can be tested locally using the stated method, or central PD-L1 testing can be completed. Results are needed for stratification and must be available prior to randomization., Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1., Participant has a life expectancy of at least 3 months., Participant has adequate organ function as defined in Table 7. (Note: A complete blood count test should be obtained without transfusion or receipt of colony-stimulating factors within 2 weeks of obtaining the sample.), Participant has recovered to Grade =1 from any prior treatment-related toxicities at the time of randomization. A participant with Grade 2 alopecia is an exception to this criterion and may qualify for this study., Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 180 days after the last dose of study treatment. (Note: duration of contraceptive use after last dose of chemotherapy must be consistent with local requirements and local approved product labels; however, the minimum duration is 180 days after last dose of chemotherapy) ? Refrain from donating sperm PLUS, either: ? Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR ? Must agree to use contraception/barrier as follows: ? Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. ? Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. b. A female participant is eligible to participate if she is not pregnant or bre

排除标准

•Participant has received prior systemic therapy for the treatment of metastatic NSCLC. Participants who have received neoadjuvant or adjuvant chemotherapy are eligible if the neoadjuvant/adjuvant therapy was completed at least 12 months prior to the development of metastatic disease., Participant has tested positive for the presence of hepatitis B surface antigen or has a positive hepatitis C antibody test result at Screening, or within 3 months prior to first dose of study treatment., Participant has an active infection requiring systemic therapy within 1 week prior to the anticipated first dose of study treatment., Participant has known HIV (positive for HIV-1 or HIV-2 antibodies)., Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. (Note: Participants with splenectomy are allowed.) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment., Participant has received systemic steroid therapy within 3 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy. Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed., Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoraco- or paracentesis) is eligible., Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of oral or IV glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary., Participant has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study treatment, or indicate it is not in the best interest of the participant to participate, in the opinion of the Investigator., Participant has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis., Participant has pre-existing peripheral neuropathy that is Grade =2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 criteria., Participant has received prior therapy with a PD-(L)1 or PD-L2 inhibitor, a CTLA-4 inhibitor, a TIM-3 inhibitor, or any other immunotherapy agent (e.g., OX40) for the treatment of cancer., Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus are permitted., Participant does not meet requirements per local prescribing guidelines for receiving treatment with either pemetrexed and cisplatin or carboplatin., Participant has sensitivity to any of the study treatments, or components thereof, or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation., Participant is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam

研究者

发起方

Glaxosmithkline Research & Development Limited

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