Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Hetero-Pembrolizumab (Hetero Biopharma Ltd, India): 200 mg of Pembrolizumab will be administered as intravenous infusion over 30 minutes every 3 weeks
Control Intervention1: RMP Pembrol
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients of 18 years and above age. 2.Histologically or cytologically confirmed diagnosis of Non Squamous type of metastatic NSCLC. 3.Tumor with PD L1 positive, preferably more than equal to 50 Percentage determined by immunohistochemistry and without any EGFR, ALK positive mutations. 4.Have not received prior systemic treatment for their advanced or metastatic NSCLC. Patients who received adjuvant or neoadjuvant therapy are eligible if the adjuvant or neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease. 5.Patients with Eastern Cooperative Oncology Group Score 0 to 1. 6.Patients with screening laboratory tests within the following criteria a.Haemoglobin greater than or equal to 9.0 g per dL b.WBC greater than or equal to 3.5 X 109 per L c.Neutrophils greater than or equal to 2.0 X 109 per L d.Platelets greater than or equal to 100 X 109 per L e.Serum transaminase levels greater than or equal to 2.5 X ULN and 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 per dL h.Calculated creatinine clearance greater than or equal to 60 mL per min, Cockcroft Gault formula. i.PT or aPTT or INR less than or equal to 1.5 X ULN unless the patient is receiving anticoagulant therapy j.Thyroid Stimulating Hormone Within normal limits
Exclusion criteria
Exclusion criteria: 1. 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] 2. Patient with symptomatic ascites or pleural effusion. 3. 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). 4. Patients with interstitial lung disease or prior pneumonitis required systemic corticosteroid therapy. 5. 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. 6. Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. 7. 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). 8. Patient with renal impairment (creatine clearance less than or equal to 60 mL/min) or receiving dialysis. 9. Patients undergone major surgery within 3 weeks prior to fist dose. 10. 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. 11. Participation in any clinical study of an investigational product within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) at the end of cycle 8 (Week 24)Timepoint: Screening and end of Cycle 8 (Week 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) at end of Cycle 4 (Week 12), Cycle 12 (Week 36) and Cycle 17 (Week 52) Timepoint: Baseline, 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)Timepoint: 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)Timepoint: Baseline end of Cycle 17 (Week 52);Pharmacokinetic parameters o Primary AUC0-tau. ss at Cycle 6 o Secondary Cmax & Ctrough.ss at Cycle 1 & 6, as applicableTimepoint: AUC0-tau. ss at Cycle 6 Cmax and Ctrough.ss at Cycle 1 & 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)Timepoint: 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)Timepoint: Baseline and end of Cycle 17 (Week 52) | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Biopharma Limited
Outcome results
None listed