ISRCTN10010669进行中（未招募）2 期
A Phase II, single-arm study of tiragolumab plus atezolizumab and bevacizumab in patients with previously untreated locally advanced unresectable or metastatic PD-L1-positive non-squamous non-small cell lung cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
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
- •1. Age =18 years at time of signing Informed Consent Form
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •3. Histologically or cytologically documented locally advanced unresectable non-small cell lung cancer (NSCLC) (i.e., Stage IIIB not eligible for definitive chemoradiotherapy), recurrent, or metastatic NSCLC (i.e., Stage IV) (per the Union Internationale Contre le Cancer/American Joint Committee on Cancer [UICC/AJCC] staging system, 8th edition) of non-squamous histology
- •4. No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
- •5. Tumour PD-L1 expression with a tumour cell (TC) =1%, as determined by the PD-L1 Immunohistochemistry (IHC) SP263 pharmDx assay performed by a central laboratory on previously obtained archival tumour tissue or tissue obtained from a biopsy at screening.
- •6. Confirmed availability of representative tumour specimens in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or at least 9 unstained serial slides, along with an associated pathology report. Measurable disease, as defined by RECIST v1.1
- •7. Life expectancy =12 weeks
- •8. Negative human immunodeficiency virus (HIV) test at screening
- •9. Negative hepatitis B surface antigen (HBsAg) test at screening
- •10. Negative hepatitis C virus (HCV) antibody test at screening
排除标准
- •1. Participants with non-squamous NSCLC known to have a sensitising mutation in the EGFR gene or an ALK fusion oncogene or ROS1 fusion oncogene
- •2. Participants with squamous NSCLC
- •3. Participants with the pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC
- •4. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4, anti-PD-1, anti-PD-L1 and anti-T cell immunoreceptor with immunoglobulin and ITIM domain (TIGIT) therapeutic antibodies
- •5. Current treatment with anti-viral therapy for HBV or HCV
- •6. Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •7. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •8. Uncontrolled tumour-related pain
- •9. History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
- •10. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participants at high risk from treatment complications
- •11. Known allergy or hypersensitivity to any component of the study drugs or formulation
- •12. Prior allogeneic stem cell or solid organ transplantation
- •13. History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •14. History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis, or colitis
- •15. Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •16. Clear tumour infiltration into the thoracic great vessels is seen on imaging
- •17. Clear cavitation of pulmonary lesions is seen on imaging
- •18. Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study
- •19. Pregnant, lactating, or breastfeeding women
研究者
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