CTRI/2026/02/104111尚未招募3 期
A Prospective, Multicenter, Randomized, Parallel Group, Double-Blind, Comparative, Active-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetic and Immunogenicity of Intravenous Infusion of Pembrolizumab (Sun Pharmaceutical Industries Limited) in comparison with Reference Medicinal Product (Keytruda) in treatment of Patients with Non-Squamous Metastatic Non-Small Cell Lung Carcinoma
Sun Pharmaceutical Industries Limited (SPIL)38 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2026年2月23日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 237
- 试验地点
- 38
研究概览
简要总结
This is a randomized, multi-centric, double-blind, active-controlled, parallel, comparative, phase III study. The study will be conducted in approximately up to 20 centres from various parts of India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval.
The total duration of the screening period will be of maximum 2 weeks (14 days).
Eligible patients will be randomized in 2:1 ratio to receive Sun’s Pembrolizumab (Test product) or Keytruda® (Comparator product) respectively.
Patients without disease progression at week 24, will continue their participation in the study till week 48 and End of Study/Efficacy and Safety follow-up visit will be 4 weeks after week 48 i.e. week 52
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, aged 18 to 65 years (both inclusive) at the time of signing informed consent 2) Histologically or cytologically confirmed diagnosis of Non-Squamous type of metastatic (stage IV) NSCLC 3) Patients expressing PD-L1 with no EGFR or ALK genomic tumour aberration 4) Has measurable disease at screening based on RECIST 1.1 5) Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- •[Patients who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.] 6) Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status at screening and randomization.
- •Life expectancy of at least 6 months.
- •Patients with following laboratory parameters at screening • Absolute neutrophil count (ANC) more than equal to 2.0 X 109/L • WBC more than equal to 3.5 X 109/L • Hemoglobin more than equal to 9.0 g/dL • Platelets more than equal to 100 X 109/L • AST and ALT levels less than equal to 2.5 X ULN (less than equal to 5 X ULN, in case of liver metastases) • Serum total bilirubin less than equal to 1.5 x ULN • calculated creatinine clearance (CrCl) more than equal to 60 mL/min (calculated using the Cockcroft-Gault Method) • International Normalized Ratio (INR) or Prothrombin Time (PT) less than equal to 1.5 X ULN unless the subject is receiving anticoagulant Therapy •Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) less than equal to 1.5 X ULN unless the subject is receiving anticoagulant therapy • TSH or FT3 and FT4 are within normal limit 9) Women of childbearing potential must have a negative urine pregnancy test at Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy throughout the study and for at least 4 months after end of treatment with Pembrolizumab (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide]).
- •[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
- •Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age] 10) Male Patients and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 4 months after end of treatment with Pembrolizumab.
- •(Note: Acceptable methods of contraception: A.
- •Male: Vasectomy, Condoms, Total abstinence; B.
- •Females: hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable], intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total sexual abstinence).
排除标准
- •Patient with history of hypersensitivity reactions to any of the study drugs including background chemotherapy or its excipients or platinum containing components or immune related reactions to monoclonal antibodies 2) Patients with predominantly squamous cell histology NSCLC. [Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, then subject is ineligible 3) Patients who have received prior antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab) 4) Patients who have received radiation therapy to the lung that is more than 30 Gy within 6 months prior to randomization. 5) Patients completing palliative radiotherapy within 7 days prior to randomization 6) Has received a live-virus vaccination prior to 30 days of randomization. Seasonal flu vaccines that do not contain live virus are permitted. 7) Has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis. 8) Has a known history of prior malignancy except if the subject has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. (criteria applicable for malignancy other than NSCLC) 9) Patient with active CNS metastases and/or carcinomatous meningitis 10) Patients on chronic steroid use. Patients with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. 11) Is unable or unwilling to take folic acid or vitamin B12 supplementation. 12) Has an active infection requiring therapy 13) Patients with positive result of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening visit. 14) Has a history or current evidence of any medical condition, psychiatric condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator or Sponsors medical monitor. 15) Known or suspected abuse of alcohol or recreational drugs 16) Patient with symptomatic ascites or pleural effusion. [A patient who is clinically stable following treatment for these conditions (including therapeutic thoraco.
- •or paracentesis) is eligible.] 17) Is pregnant or breastfeeding, or expecting to conceive or father children during the study. 18) Patients with a history of Interstitial Lung Disease 19) Participation in any clinical study of an investigational product within the previous 3 months 20) Employee of the Sponsor or Investigator or study centre with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees of Sponsor or the Investigator.
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (38)
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