A randomized, double-blind, multi-center, active-control, parallel group study to compare efficacy, safety, immunogenicity and pharmacokinetics of Lupin Nivolumab (LUBT022) with Innovator Nivolumab in patients with locally advanced or metastatic non-small cell lung cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Lupin Limited
- Enrollment
- 202
- Locations
- 59
- Primary Endpoint
- Overall Response Rate (ORR)
Study Overview
Brief Summary
The proposed study is a randomized, double blind, parallel arm clinical trial to compare the efficacy, safety, immunogenicity and pharmacokinetics in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) following exposure cycle 12 (24 weeks). This is a monotherapy. The trial will include a screening period (upto 4 weeks), and a double-blind treatment period. The eligible patient will be randomized and receive test or reference arm. Patient will be dosed on 3 mg/kg solution by intravenous (IV) route every 2 weeks till cycle 12 (week 24-last dose) or until disease progression or discontinued from the study due to any other reasons. Overall response rate will be assessed (radiological assessment) as per RECIST 1.1 criteria. PK parameters will be evaluated as Cmax, AUC, terminal phase half-life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female 18 years of age Patient with histologically or cytologically confirmed diagnosis Patients must have experienced disease recurrence or progression after one first line therapy Patients must have received at least 2 cycles of chemotherapy Patients who received adjuvant neoadjuvant or definitive chemoradiation therapy within 6 months Patients with recurrent disease greater than 6 months Presence of at least one measurable target lesion as per RECIST criteria version 1.1 ECOG performance status of 0 or 1 8 Screening laboratory values that meet the ANC Platelets Hemoglobin Serum bilirubin AST and ALT Serum creatinine creatinine clearance criteria as per protocol.
Exclusion Criteria
- •Patients with CNS metastases are eligible only if the metastases are adequately treated Patient with a condition requiring systemic treatment with either corticosteroids Patient with active known or suspected autoimmune disease All toxicities attributed to prior anti-cancer therapy Prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents Prior radiotherapy or radiosurgery received within 2 weeks prior to screening Patients with interstitial lung disease Prior therapy History of other primary malignancy Positive test result for HIV Hepatitis B Hepatitis C History of allergy or intolerance History of hypersensitivity reactions Major surgical procedure or significant traumatic injury within 28 days prior to screening Received any therapy Pregnant or lactating women & all men who not follow contraceptive measure.
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: Overall Response Rate (ORR) at Baseline, Cycle 5, Cycle 9, EOS,
Secondary Outcomes
- Efficacy:(• Disease control rate (DCR))
Investigators
Dr Chirag Shah
Lupin Ltd