CTIS2023-505057-40-00招募中1 期
A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non Small Cell Lung Cancer - 213824
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 280
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
- •Is capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol., If of childbearing potential, female participants must be willing to use adequate contraception. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: Is a woman of non-childbearing potential as defined in the protocol or Is a woman of childbearing potential and using a contraceptive method that is highly effective as described in the protocol Female participant agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. A woman of childbearing potential must not be pregnant, Is, at the time of signing the ICF, at least 18 years old or the legal age of consent in the jurisdiction in which the study is taking place., Has a histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or nonsquamous)., Has not received prior systemic therapy for their locally advanced or metastatic NSCLC., Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC., Has a PD-L1-high (TC/TPS >/=50%) tumor, Has measurable disease based on RECIST 1.1 as determined by the investigator., Has an ECOG PS of 0 or 1., Has adequate organ function as defined in the protocol
排除标准
- •Has NSCLC with a tumor that harbors any of the following molecular alterations: a. EGFR mutations that are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19, exon 20 insertion mutation, and exon 21 [L858R] substitution mutation). All participants with nonsquamous histology must have been tested for EGFR mutation status using a tissue-based test; use of an approved test is strongly encouraged. Participants with squamous histology do not need to be tested for EGFR mutation status. Participants with nonsquamous histology and unknown or indeterminate EGFR status are excluded. b. ALK translocations that are sensitive to available targeted inhibitor therapy. All participants with nonsquamous histology must have been tested for ALK fusion mutation status using a tissue-based test; use of an approved test is strongly encouraged. Participants with squamous histology do not need to be tested for ALK mutation status. Participants with nonsquamous histology and with unknown or indeterminate ALK status are excluded. c. Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC., Has a known HIV infection., Has a history of severe hypersensitivity to mAbs or to any of the excipients in the formulations of the components of the study interventions, Has received any live vaccine within 30 days prior to first dose of study intervention., Has any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric, or other condition that could, in the opinion of the investigator, interfere with participant’s safety, obtaining informed consent, or compliance with the study procedures, Has symptomatic ascites, pleural effusion, or pericardial effusion., Has active inflammatory bowel disease, acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis, Has a history or evidence of cardiac abnormalities within the 6 months prior to enrollment, Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis., Has had major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30 Gy (for any purpose, including palliatively) within 6 months prior to the first dose of study intervention., Has received prior therapy with any immune-checkpoint inhibitors, Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime, Is, at the time of signing the ICF, a regular user (including recreational use) of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol) that, in the opinion of the investigator, would interfere with the evaluation of the study intervention or interpretation of safety., Has a positive test for the presence of HBsAg at Screening or within 3 months prior to first dose of study intervention., Has a positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study intervention., Has a positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention., Has advanced, symptomatic, or visceral spread and is considere
研究者
相似试验
招募中
2 期
A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non Small Cell Lung CancerNSCLClung cancerNL-OMON51766GlaxoSmithKline20
招募中
1 期
Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants with PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and NeckCTIS2023-503428-24-00Glaxosmithkline Research & Development Limited350
招募中
2 期
Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants with Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung CancerJPRN-jRCT2051220100Ishibashi Hideyasu300
招募中
2 期
Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants with PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and NeckJPRN-jRCT2031230371Ishibashi Hideyasu240
进行中（未招募）
1 期
Phase 2 Platform Study of Novel Immunotherapy Combinations in Participants with Previously Untreated Advanced/Metastatic NonSmallCell Lung Canceron-small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-005115-32-HUGlaxoSmithKline Research & Development Limited300