A randomized, open-label, Phase 3 study to evaluate zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy for the first-line treatment of patients with metastatic non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations - STAR-121

Ali Nasermoaddeli0 sites50 target enrollmentNovember 10, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 10, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Ali Nasermoaddeli

•Life expectancy \>\= 3 months.
•\- Pathologically documented NSCLC that meets both of the criteria below:
•\- Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
•\- Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
•\- Have no known genomic alterations in ROS proto\-oncogene 1 (ROS1\), neurotrophic tyrosine receptor kinase (NTRK), proto\-oncogene B\-raf (BRAF), RET mutations, or other actionable driver oncogenes with approved therapies (actionable genomic alteration).
•\- Have not received prior systemic treatment for metastatic NSCLC.
•\- Measurable disease by CT or MRI as per RECIST v1\.1 criteria by investigator assessment.
•\- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1\.
•\- Have adequate organ functions

•\- Have mixed small\-cell lung cancer and NSCLC histology.
•\- Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
•\- Received prior treatment with any anti\-PD\-1, anti\-PD\-L1, or any other antibody targeting an immune checkpoint.
•\- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
•\- Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
•\- Have an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease\-modifying agents, corticosteroids, or immunosuppressive drugs).
•\- Are receiving chronic systemic steroids.
•\- Have significant third\-space fluid retention
•\- Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•\- Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.