跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/CTRI/2024/02/062974
CTRI/2024/02/062974尚未招募3 期

A Phase III randomised, double-blind, multicentre study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 (proposed pembrolizumab biosimilar) and Keytruda in subjects with metastatic non-squamous non-small cell lung cancer - NI

Samsung Bioepis Co Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
3 期
状态
尚未招募
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

入排标准

入选标准

  • •1. Subjects who have a histologically confirmed or cytologically confirmed diagnosis of stage IV (M1a, M1b, or M1c of American Joint Committee on Cancer 8th edition) nonsquamous NSCLC.
  • •2. Subjects who have at least one measurable lesion per RECIST v1.1 criteria on imaging modalities (computed tomography scan or magnetic resonance imaging scan) by the local site Investigator assessment.
  • •3. Subjects who have a documented PD-L1 result by the US FDA-approved test (PDL1 IHC 22C3 pharmDx assay) within 12 weeks from the date of Randomisation.
  • •a. If no prior PDL1 result is available at Screening, the subject must be assessed for PD-L1 result prior to the date of Randomisation using the stated method (PDL1 IHC 22C3 pharmDx assay) at a qualified local laboratory. For PD-L1 assessment, newly obtained (core or excisional) biopsy or archival tumour tissue sample (obtained within 12 weeks from the date of Randomisation) from locations not irradiated prior to biopsy is acceptable and formalin-fixed paraffin embedded (FFPE) tumour tissue sample blocks are preferred. Fine needle aspirates or biopsy, brushing, cell blocks, or tumour tissue from bone metastases that is subject to decalcification are not acceptable.
  • •4. Subjects who have NOT received prior systemic therapy (including cytotoxic chemotherapy, targeted therapy, or antineoplastic biological therapy) for their metastatic NSCLC.
  • •5. Male or female aged greater than equal to 18 years old at the time of signing the informed consent form (ICF), if local regulations are different in this regard, follow the local regulations.
  • •6. ECOG performance status of 0 or 1.
  • •7. Subjects who have a life expectancy of at least 3 months from Screening.
  • •8. Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures.
  • •9. Female subjects of nonchildbearing potential female (e.g., having congenital or acquired condition that prevents childbearing, having history of hysterectomy and-or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation or occlusion, or postmenopausal, OR childbearing potential who have a negative urine or serum pregnancy test within 3 days prior to receiving the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • •10. Must agree to use adequate methods of contraception starting with the first dose of study treatment through 4 months after the last dose of IP administration and 6 months after the last dose of non-IPs administration.
  • •11. Subjects must have adequate organ functions at Screening as indicated by the clinical laboratory values.
  • •a. Haematological
  • •i. Absolute neutrophil count (ANC) greater than equal to 1,500 per µL without granulocyte colonystimulating factor (G-CSF) support within 4 weeks prior to the date of
  • •Randomisation.
  • •ii. Platelet count greater than equal to 100,000 per µL without platelet transfusion within 4 weeks prior to the date of Randomisation.
  • •iii. Haemoglobin greater than equal to 9.0 g per dL without erythropoietin dependency and transfusion within 4 weeks prior to the date of Randomisation.
  • •i. Calculated creatinine clearance greater than equal to 50 mL per min.
  • •i. Serum total bilirubin less than equal to 1.5 × upper limit of normal (ULN).
  • •ii. Aspartate tra

排除标准

  • •1.Subjects who have documentation of presence of tumour activating epidermal growth factor receptor (EGFR) mutations OR presence of anaplastic lymphoma kinase (ALK) rearrangements OR presence of c-ros oncogene 1 (ROS1) rearrangements.
  • •2.Subjects who are currently receiving or have received prior treatment with any of the following, including in the adjuvant neoadjuvant setting:
  • •a.Any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent OR an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, LAG-3, TIGIT, OX40, and CD137, etc.).
  • •3.Subjects who have received prior palliative radiotherapy within 2 weeks prior to the date of Randomisation or received lung radiation therapy of more than 30 Gray (Gy) within 6 months prior to the date of Randomisation. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • •4.Subjects who have predominantly squamous cell histology NSCLC. Mixed tumours will be categorised by the predominant cell type; if small cell elements are present, the subject is ineligible.
  • •5.Subjects who have a known severe hypersensitivity reaction to treatment with another monoclonal antibody or any component of platinum-containing compounds or pemetrexed.
  • •6.Subjects who are unable or unwilling to take folic acid or vitamin B12 supplementation.
  • •7.Subjects who are currently participating in any interventional clinical study or have participated in a study of an investigational drug within 30 days or 5 half-lives of the investigational drug being studied prior to the date of Randomisation, whichever is longer, or using an investigational device within 30 days prior to the date of Randomisation.
  • •8.Subjects who are expected to require any other form of systemic or localised antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, or surgical resection).
  • •9.Subjects who have a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
  • •10.Subjects who have a history of interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organising pneumonia).
  • •11.Subjects who have a history of malignancy other than NSCLC except if the subjects have undergone potentially curative therapy with no evidence of that disease recurrence for 5 years prior to Screening.
  • •12.Subjects who have known untreated central nervous system (CNS) metastases or known carcinomatous meningitis.
  • •a.Subjects with untreated and asymptomatic brain metastases (i.e., no neurological symptoms, no requirements for corticosteroids, no surrounding oedema, and no lesion greater than equal to 1.0 cm) first detected at Screening may participate but will require regular scan of the brain as a site of disease.
  • •b.Subjects with previously treated brain metastases may participate provided that they are clinically and neurologically stable, and have no evidence of new or enlarging brain metastases (as determined by 2 brain images, both of which are obtained after treatment of the brain metastases. One of the brain images should be a brain image obtained at Screening and the other should be a brain image obtained at least 4 weeks prior to Screening). In addition, they are off systemic steroids for at least 2 weeks prior to the date of Randomisation.
  • •13.Subjects with an a

研究者

相似试验

已完成
不适用
A Phase III randomised, double-blind, multicentre study to evaluate the safety and efficacy of 1592U89 (abacavir) in human immunodeficiency virus 1-infected patients with aquired immune deficiency syndrome dementia complexHIV-1 infection with AIDS dementiaInfections and InfestationsHIV, AIDS
ISRCTN53707238GlaxoSmithKline (UK)90
招募中
1 期
Study which tests 2 medications (SB27, Keytruda) to compare how effective, safe and well tolerated in a large number of metastatic non-squamous non-small cell lung cancer patients
CTIS2023-507448-36-00Samsung Bioepis Co. Ltd.616
进行中（未招募）
1 期
A study to evaluate the efficacy, safety, and tolerability of dolutegravir pluslamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected patients that have not been treated yet.Human Immunodeficiency Virus-1 infectionMedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
EUCTR2016-000459-28-PTViiV Healthcare UK Limited700
进行中（未招募）
1 期
A study to evaluate the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected patients that have not been treated yet.Human Immunodeficiency Virus-1 infectionMedDRA version: 19.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
EUCTR2015-004418-95-ESViiV Healthcare UK Limited719
进行中（未招募）
1 期
A study to evaluate the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected patients that have not been treated yet.
EUCTR2015-004418-95-BEViiV Healthcare UK Limited719