Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Lupin Nivolumab (LUBT022): dose is 3 mg/kg every 14 days 30 - minute
intravenous infusion for upto 12 cycles
Control Intervention1: Innovators Nivolumab (Opdivo /Opdyta ): dose is 3 m
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR)Timepoint: Overall Response Rate (ORR) at Baseline, Cycle 5, Cycle 9, EOS, | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Disease control rate (DCR) Safety: Incidence of TEAEs Immunogenicity: Proportion of patients with binding and neutralizing antibodies at the end of Cycle 4, 8, and 12 Pharmacokinetics: Descriptive assessment of PK parameters in subgroupTimepoint: Efficacy: Disease control rate (DCR) at the end of Cycle 12 Safety: Incidence of TEAEs baseline to End of study till cycle 12 Immunogenicity: immunogenicity will be collected pre-dose at Cycle 1, at the end of Cycle 4 (pre-dose of Cycle 5), Cycle 8 (pre-dose of Cycle 9), and at end of Cycle 12 (pre-dose of EOS) Descriptive assessment of PK parameters in subgroup at C1D1,C1D2,C1D3,C1D7, C4D1, C6D1, C8D1, C10D1, C12D1 and at EOS | — |
Countries
India
Contacts
Public ContactDr Neelam Kardekar
Lupin Ltd
Outcome results
None listed