A Phase III, Prospective, Randomized, Multicenter,Comparative, Double blind, Parallel-group Study toInvestigate the Efficacy, Safety, and Pharmacokineticsof ZRC-3276 Versus Opdivo® (Nivolumab) in Subjectswith locally advanced or Metastatic Non-Small CellLung Cancer

Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited0 sites248 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited
Enrollment: 248
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 7, 2024

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited

Eligibility Criteria

Inclusion Criteria

•1\.Male or female with\= 18 years of age
•2\.Subjects with histologically or cytologically\-documented locally advanced or metastatic NSCLC who present with Stage IIIB/IIIC/Stage IV or recurrent or progressive disease following multi\-modality therapy (radiation therapy, surgical resection or definitive chemo radiation therapy for locally advanced disease).
•Note: Subjects eligible for study therapy after acceptable prior therapy are as specified
•o Subjects must have experienced disease recurrence or progression during or after one first line therapy for advanced or metastatic disease.
•o A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy. Subjects must have received at least 2 cycles of platinum doublet based chemotherapy before discontinuation for toxicity.
•o Maintenance therapy following first line chemotherapy is not considered as a separate regimen of therapy and could comprise continuation of one or more of the agents used in the first\-line therapy regimen or switch to another non cross\-resistant agent. The initiation of maintenance therapy requires the lack of progressive disease with front\-line therapy. Subjects who showed disease progression during or after maintenance therapy will be eligible.
•o Treatment given for locally advanced disease is not considered as a line of therapy for advanced disease. Participants with recurrent disease \>6 months after platinum containing adjuvant, neoadjuvant or definitive chemo\-radiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet\-based regimen given to treat the recurrence,
•are eligible.
•o Experimental therapies when given as separate regimen are considered as separate line of therapy. Subject who received experimental therapies for disease progression after fist line therapy will not be eligible.
•\- Participants who received adjuvant, neoadjuvant chemotherapy or definitive chemo\-radiation therapy given for locally advanced disease, and developed recurrent disease within 6 months of completing therapy are eligible.

Exclusion Criteria

•1\. Subjects with CNS metastases, except for treated asymptomatic CNS metastases, provided all of the following criteria are met:
•a. Only supra\-tentorial metastases allowed (i.e., no metastases to midbrain,
•pons, medulla, or spinal cord)
•b. No evidence of interim progression or hemorrhage after completion of
•CNS\-directed therapy
•c. No ongoing requirement for corticosteroids as therapy for CNS disease
•(anticonvulsants at a stable dose are allowed at least two weeks prior to
•d. No stereotactic radiation within 14 days or whole\-brain radiation within 28
•days prior to randomization
•e. Leptomeningeal disease (i.e. carcinomatous meningitis)