NL-OMON52181撤回3 期
A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGBA1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD L1 Selected Non- Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy - BGB-A317-A1217-301 (AdvanTIG-301)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 9
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
- •Each patient eligible to participate in this study must meet all the following
- •Histologically or cytologically confirmed, unresectable locally advanced
- •Stage III NSCLC
- •(AJCC Cancer Staging Manual 2017, derived from International Association for
- •the Study of
- •Lung Cancer [IASLC]) prior to cCRT.
- •Have completed >= 2 cycles of platinum-based chemotherapy concurrent with
- •radiotherapy.
- •For patients who are recovering from toxicities associated with the prior
- •treatment, the first
- •dose of study drug(s) may be delayed by up to 42 days from the end of the cCRT.
- •recommended to screen the patients within 14 days after the completion of cCRT.
- •Have not experienced PD following definitive, platinum-based cCRT.
- •CONFIDENTIAL
- •Agree to provide archival tissue (formalin-fixed paraffin-embedded block
- •containing tumor
- •[preferred] or approximately 6 to 15 freshly cut unstained slides) or fresh
- •biopsy (if archival
- •tissue is not available) for prospective central evaluation of PD-L1 levels and
- •retrospective
- •analysis of other biomarkers. PD-L1 status will be assessed centrally in either
- •a previously
- •obtained archival tumor tissue or fresh tissue obtained from a biopsy collected
- •prior to the
- •first dose of cCRT via VENTANA PD-L1 (SP263) assay. Only patients with PD-L1
- •expression on >= 1% of TC are eligible.
排除标准
- •Patients who meet any of the following criteria are NOT eligible to enroll:
- •Prior therapy with an anti-programmed cell death-1(PD-1), anti-PD-L1,
- •anti-PD-L2,
- •anti-T-cell immunoglobulin and ITIM domain (TIGIT), or any other antibody or
- •specifically targeting T-cell co-stimulation or checkpoint pathways.
- •Diagnosed with NSCLC that harbors an epidermal growth factor receptor
- •(EGFR)sensitizing
- •mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene
- •translocation, or RET
- •gene rearrangement.
- •Distant metastasis identified by imaging assessment and/or other examinations
- •definitive, platinum-based cCRT.
- •Have received chemotherapy and radiotherapy with <= 1 cycle overlap for LA
- •Have received systemic anticancer treatment besides the specified cCRT.
- •Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT. Patients with
- •irreversible
- •toxicity that is not reasonably expected to be exacerbated by study treatment
- •included (eg, hearing loss) after consultation with the medical monitor.
- •Any grade pneumonitis from prior cCRT.
- •Active autoimmune diseases or history of autoimmune diseases that may
- •Any active malignancy <= 2 years before the first dose of study drug(s) except
- •for the specific
- •cancer under investigation in this study and any locally recurring cancer that
- •has been treatedcuratively.
- •Any conditions that required systemic treatment with either corticosteroids
- •(> 10 mg daily ofprednisone [in Japan, prednisolone] or equivalent) or other
- •immunosuppressive medication
- •<= 14 days before the first dose of study drug(s).
- •History of interstitial lung disease, non-infectious pneumonitis, or
- •uncontrolled lung diseases
- •including pulmonary fibrosis, acute lung diseases, etc.
- •Infections (including tuberculosis infection, etc) that required systemic
- •antibacterial,
- •antifungal, or antiviral therapy within 14 days before the first dose of study
- •A history of severe hypersensitivity reactions to other monoclonal antibodies
- •or history of
- •hypersensitivity to the ingredients of tislelizumab or ociperlimab.
- •Receipt of any immunotherapy (eg, interleukin, interferon, thymosin [not
- •approved in
- •Japan], etc) or any investigational therapies within 14 days or 5 half-lives
- •(whichever is
- •longer) before the first dose of study treatment.
研究者
相似试验
进行中（未招募）
1 期
A phase 3 study evaluating ociperlimab plus tislelizumab versus durvalumabocally Advanced, Unresectable, PD L1 Selected Non- Small Cell Lung Cancer Where Disease Has Not Progressed After Concurrent ChemoradiotherapyMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-004656-14-DEBeiGene, Ltd.700
进行中（未招募）
1 期
A Phase 3 study to evaluate safety and efficacy of the combination of for Bel- CHOP/ Fol-COP drugs against CHOP in newly diagnosed Peripheral T-Cell Lymphoma (blood cancer) patientsCTIS2023-507803-76-00Acrotech Biopharma Inc.499
招募中
不适用
A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) who Received Radical ResectioKCT0004525Asan Medical Center286
招募中
1 期
A study to learn how well odronextamab combined with chemotherapy works and how safe it is compared to rituximab and chemotherapy in adult participants with previously untreated follicular lymphomaFollicular lymphomaMedDRA version: 21.1Level: PTClassification code: 10061170Term: Follicle centre lymphoma follicular grade I II III Class: 100000004864CTIS2022-502113-28-00Regeneron Pharmaceuticals Inc.717
进行中（未招募）
1 期
A study of nivolumab and ipilimumab in untreated patients with stage 3 NSCLC that is unable or not planned to be removed by surgeryEUCTR2019-001222-98-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO1,400