CTRI/2024/02/062974进行中（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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 616
- 试验地点
- 10
- 主要终点
- The primary objective is to demonstrate the equivalence in efficacy of SB27 to Keytruda, in terms of objective response rate (ORR) at Week 24 in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC).
研究概览
简要总结
This is a Phase III, randomized, double-blind, parallel group, and multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of SB27 compared to Keytruda in subjects with metastatic non-squamous NSCLC. Subjects will be randomised in a 1:1 ratio to receive either SB27 or Keytruda 200 mg intravenously every 3 weeks concurrently with chemotherapy (pemetrexed 500 mg/m2 [with vitamin supplementation] intravenous (IV) infusion over 10 minutes every 3 weeks and carboplatin area under the curve [AUC] 5 IV infusion over 15-60 minutes every 3 weeks for the first 4 cycles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
- •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.
- •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.
- •Subjects who have NOT received prior systemic therapy (including cytotoxic chemotherapy, targeted therapy, or antineoplastic biological therapy) for their metastatic NSCLC.
- •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.
- •ECOG performance status of 0 or
- •Subjects who have a life expectancy of at least 3 months from Screening.
- •Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures.
- •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.
- •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.
- •Subjects must have adequate organ functions at Screening as indicated by the clinical laboratory values.
- •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.
- •Platelet count greater than equal to 100,000 per μL without platelet transfusion within 4 weeks prior to the date of Randomisation.
- •Haemoglobin greater than equal to 9.0 g per dL without erythropoietin dependency and transfusion within 4 weeks prior to the date of Randomisation.
- •Calculated creatinine clearance greater than equal to 50 mL per min.
- •Aspartate transaminase (serum glutamic oxaloacetic transaminase) and Alanine transaminase (serum glutamic pyruvate transaminase) less than equal to 2.5 × ULN.
- •Coagulation i.
- •International normalised ratio (INR) or prothrombin time (PT) less than equal to 1.5 × ULN unless the subject is receiving anticoagulant therapy.
- •Activated partial thromboplastin time (aPTT) less than equal to 1.5 × ULN unless the subject is receiving anticoagulant therapy.
- •Subjects receiving therapeutic anticoagulation should be on a stable dose, and PT or INR or aPTT is within therapeutic range of intended use of anticoagulants.
- •Endocrine i.
- •Thyroid stimulating hormone (TSH) is within normal limits.
排除标准
- •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.
- •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.).
- •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.
- •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.
- •Subjects who have a known severe hypersensitivity reaction to treatment with another monoclonal antibody or any component of platinum-containing compounds or pemetrexed.
- •Subjects who are unable or unwilling to take folic acid or vitamin B12 supplementation.
- •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.
- •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).
- •Subjects who have a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
- •Subjects who have a history of interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organising pneumonia).
- •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.
- •Subjects who have known untreated central nervous system (CNS) metastases or known carcinomatous meningitis.
- •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.
- •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.
- •Subjects with an active or known autoimmune disease that has required systemic treatment including disease modifying agents, corticosteroids, or immunosuppressive drugs within 1 year prior to the date of Randomisation, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- •Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- •Subjects who have an active infection requiring systemic therapy within 2 weeks prior to the date of Randomisation or history of severe infections within 4 weeks prior to the date of Randomisation, including, but not limited to, hospitalisation for complications of infection, bacteraemia, or severe pneumonia.
- •Subjects who have a positive test result for human immunodeficiency virus (HIV) at Screening, or have a history of acquired immunodeficiency syndrome (AIDS) or a history of primary immunodeficiency.
- •Subjects with history of active infection (acute or chronic) or positive test of hepatitis B virus (HBV, defined as hepatitis B surface antigen [HBsAg] positive OR HBsAg negative and hepatitis B core antibody [HBcAb] positive) and hepatitis C virus (HCV, defined as HCV ribonucleic acid [RNA] positive).
- •Subjects who have any clinically significant disease or disorder or laboratory abnormality that prevent the subjects from completing the study or might confound the results of the study at the discretion of the Investigator.
- •Subjects who have a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- •Subjects who are a regular user of any illicit drugs or had a recent history of substance abuse (including alcohol) within 1 year prior to Screening.
- •Subjects who have clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or peritoneal carcinomatosis.
- •Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study.
- •Subjects who have received a live, or live attenuated vaccine within 30 days prior to the date of Randomisation.
- •Killed, inactivated, or recombinant vaccine is allowed.
- •Non-live or non-live attenuated Coronavirus Disease 2019 (COVID-19) vaccines (including messenger ribonucleic acid [mRNA]-based vaccines) are permitted.
- •Seasonal influenza vaccines that do not contain a live or live-attenuated virus are permitted.
- •Subjects who have had major surgery within 4 weeks prior to the date of Randomisation and inadequate wound healing at the discretion of the Investigator at Screening (e.g., requiring more extensive procedure than local anaesthesia [involving general anaesthesia or respiratory assistance or regional anaesthesia] or open lung biopsy) or expected major surgical procedure during the study.
- •Subjects who are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose less than equal to 1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam) and subjects who require phenytoin or fosphenytoin.
- •Subjects who have a known history of active tuberculosis (TB).
- •Subjects who have had an allogeneic tissue or solid organ transplant.
- •Subjects who are on any systemic corticosteroid therapy or on any other form of immunosuppressive medication within 2 weeks prior to the date of Randomisation.
- •The following are exceptions to this criterion: a.
- •Intranasal steroids, inhaled steroids, topical steroids, or local steroid injections (e.g., intra-articular injection).
- •Steroids as premedication for hypersensitivity reactions (e.g., premedication for CT scan).
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
结局指标
主要结局
The primary objective is to demonstrate the equivalence in efficacy of SB27 to Keytruda, in terms of objective response rate (ORR) at Week 24 in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC).
时间窗: ORR at 24 weeks
次要结局
- To evaluate the efficacy of SB27 compared to Keytruda.(- ORR at specific time points other than primary endpoint)
- To evaluate the safety and tolerability of SB27 compared to Keytruda(Throughout the study)
- To evaluate the pharmacokinetics (PK) of SB27 compared to Keytruda(At Cycle 1, 3, 6, and 9)
- To evaluate the immunogenicity of SB27 compared to Keytruda(At Cycle 1, 3, 6, 9, and EOT or ET follow-up visit of the Main Study)
研究者
Dr Shekhar Dawkhar
Fortrea Development India Private Limited
研究点 (10)
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