2023 World Conference on Lung Cancer (Posters)-P2.08. STAR-121: Phase 3 Study of DOM and ZIM plus Chemo vs Pembro plus Chemo in 1L mNSCLC with No Actionable Gene Alterations

P2.08. STAR-121: Phase 3 Study of DOM and ZIM plus Chemo vs Pembro plus Chemo in 1L mNSCLC with No Actionable Gene Alterations - PDF(Slides)

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The STAR-121 study is a phase 3 randomized clinical trial that aims to compare the effectiveness of domvanalimab and zimberelimab in combination with chemotherapy versus pembrolizumab and chemotherapy as first-line treatment for patients with metastatic non-small cell lung cancer (mNSCLC) without actionable gene alterations. The study involves approximately 720 participants and is currently enrolling patients globally. The primary objectives of the study are to evaluate the effects of the two treatment combinations on progression-free survival and overall survival.<br /><br />Domvanalimab is a monoclonal antibody that blocks the interaction between T cell Ig and ITIM domain (TIGIT) and its ligand CD155, reducing immunosuppression and promoting antitumor activity. Zimberelimab is an anti-programmed death-1 (PD-1) antibody that has demonstrated antitumor activity in previous studies.<br /><br />The study will assess several secondary endpoints, including objective response rate, duration of response, safety, and quality of life. The effects of the treatments on biomarkers in tumor and blood samples will also be analyzed.<br /><br />Patients eligible for the study must have stage IV NSCLC and measurable disease, and should not have received prior systemic treatment for mNSCLC. Exclusion criteria include active autoimmune disease, untreated central nervous system metastases, and prior treatment with immune checkpoint inhibitors targeting PD-1/PD-L1.<br /><br />The study design involves randomization of participants into three groups (A, B, or C) based on baseline PD-L1 tumor proportion score, histology, and geographic region. Group A receives domvanalimab and zimberelimab with chemotherapy, Group B receives pembrolizumab with chemotherapy, and Group C serves as an exploratory group. The study will be conducted globally, with sites in North America, South America, Europe, and Asia.<br /><br />The researchers aim to evaluate the efficacy and safety of domvanalimab and zimberelimab in combination with chemotherapy as a potential first-line treatment option for mNSCLC patients without actionable gene alterations. The study will provide valuable insights into the use of dual checkpoint inhibitors in improving clinical outcomes for this patient population.

Asset Subtitle

Delvys Rodriguez-Abreu

Meta Tag

Speaker Delvys Rodriguez-Abreu

Topic Metastatic NSCLC: Immunotherapy - TIPs

Keywords

STAR-121 study

domvanalimab

zimberelimab

chemotherapy

pembrolizumab

mNSCLC

progression-free survival

overall survival

TIGIT

PD-1