CTRI/2025/07/090716招募中3 期
A Prospective, Randomized, Double Blind, Multiple Dose, Multicenter, Active Controlled, Comparative, Parallel Study to Evaluate the Efficacy, Safety, Pharmacokinetic and Immunogenicity of Intravenous Infusion of Hetero-Pembrolizumab (Hetero Biopharma Ltd, India) and Reference Medicinal Product (Pembrolizumab, Merck Sharp & Dohme B.V) in Patients with Non- Squamous Type of Metastatic Non-Small Cell Lung Carcinoma (mNSCLC).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 20
- 主要终点
- Objective response rate (ORR) at the end of cycle 8 (Week 24)
研究概览
简要总结
This study is a double blind, randomized, active controlled, parallel group clinical studyto evaluate the efficacy, safety, pharmacokinetics and Immunogenicity of IntravenousInfusion of Hetero – Pembrolizumab and Reference-Pembrolizumab in Patients withNon-Squamous Type of Metastatic Non-Small Cell Lung Carcinoma (NSCLC). Thestudy will consist of up to 21-days screening period, 24 weeks of treatment period followedby primary analysis.Approximately 228 patients will be enrolled in Hetero-Pembrolizumab or Reference-Pembrolizumab.Patients with histologically or cytologically confirmed with Non-Squamous type ofmetastatic NSCLC with PD-L1 positive (Expression greater than or equal to 50 percentage) determined byimmunohistochemistry, without any EGFR, ALK positive mutations, measurable diseasebased on RECIST 1.1, not received prior systemic treatment for their advanced/metastaticNSCLC and ECOG score of 0-1 will be enrolled in this study.All patients will be administered either Hetero-Pembrolizumab or Reference-Pembrolizumab for 17 cycles along with standard chemotherapeutic regimen ofCarboplatin and Pemetrexed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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 patients of
- •65 years of age.
- •Histologically or cytologically confirmed diagnosis of Non Squamous type of metastatic NSCLC.
- •Tumor with PD-L1 positive (Expression greater than or equal to 50 percent) determined by immunohistochemistry and without any EGFR, ALK positive mutations.
- •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.]
- •Patients with Eastern Cooperative Oncology Group (ECOG) Score 0 –
- •Patients with screening laboratory tests within the following criteria: a. Haemoglobin greater than or equal to 9.0 g/dL b. WBC greater than or equal to 3.5 X 109/L c. Neutrophils greater than or equal to 2.0 X 109/L d. Platelets greater than or equal to 100 X 109/L e. Serum transaminase levels greater than or equal to 2.5 X ULN (less than or equal to 5 X ULN, in case of liver metastases) f. Serum Bilirubin less than or equal to 1.5 x ULN in the absence of liver metastases g. Serum creatinine levels less than or equal to 1.5 mg/dL h. Calculated creatinine clearance greater than or equal to 60 mL/min (Cockcroft-Gault formula) i. PT/ aPTT /INR less than or equal to 1.5 X ULN unless the patient is receiving anticoagulant therapy j. Thyroid Stimulating Hormone (TSH) – Within normal limits.
排除标准
- •Predominantly squamous cell histology NSCLC.
- •[Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible]
- •Patient with symptomatic ascites or pleural effusion.
- •Patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose less than or equal to 1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- •Patients with interstitial lung disease or prior pneumonitis required systemic corticosteroid therapy.
- •Received radiation therapy to the lung that is greater than or equal to 30 Gy within 6 months of the first dose of trial treatment.
- •Has received a live-virus vaccination within 30 days of planned treatment start.
- •Seasonal flu vaccines that do not contain live virus are permitted.
- •Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (any antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways).
- •Patient with a known history of prior malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- •Participation in any clinical study of an investigational product within the previous 3 months.
结局指标
主要结局
Objective response rate (ORR) at the end of cycle 8 (Week 24)
时间窗: Screening and end of Cycle 8 (Week 24)
次要结局
- Objective Response Rate (ORR) at end of Cycle 4 (Week 12), Cycle 12 (Week 36) and Cycle 17 (Week 52)
- Progression-free Survival (PFS) at the end of Cycle 8 (Week 24), Cycle 12 (Week 36) and Cycle 17 (Week 52)(Baseline at the end of Cycle 8 (Week 24), Cycle 12 (Week 36) and Cycle 17 (Week 52))
- Overall Survival (OS) at the end of Cycle 17 (Week 52)(Baseline end of Cycle 17 (Week 52))
- Pharmacokinetic parameters(o Primary – AUC0-tau. ss at Cycle 6)
- Comparative incidence and titers of anti-Pembrolizumab antibodies at Baseline, end of Cycle 4 (Week 12), Cycle 8 (week 24), Cycle 12 (Week 36) and Cycle 17 (Week 52)(Baseline, end of Cycle 4 (Week 12), Cycle 8 (week 24), Cycle 12 (Week 36) and Cycle 17 (Week 52))
- Comparative treatment emergent adverse events by monitoring significant clinical signs and symptoms and laboratory abnormalities till end of Cycle 17 (Week 52)(Baseline and end of Cycle 17 (Week 52))
研究者
Dr Shubhadeep Sinha
Hetero Biopharma Limited
研究点 (20)
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