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)

  • STATUS
    Recruiting
  • End date
    Dec 22, 2027
  • participants needed
    720
  • sponsor
    Gilead Sciences
Updated on 22 October 2022
paclitaxel
tyrosine
measurable disease
growth factor
BRAF
pemetrexed
carboplatin
pembrolizumab
epidermal growth factor receptor
ROS1
RET
EGFR
cancer chemotherapy
NTRK
epidermal growth factor
lung carcinoma
proto-oncogene tyrosine-protein kinase ros

Summary

The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

Details
Condition Non-small Cell Lung Cancer
Treatment cisplatin, carboplatin, Paclitaxel, Pembrolizumab, Pemetrexed, Nab-paclitaxel, Zimberelimab, Domvanalimab
Clinical Study IdentifierNCT05502237
SponsorGilead Sciences
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Have mixed small-cell lung cancer (SCLC) 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
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has had an allogenic tissue/solid organ transplant
Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted
Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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