Study to Evaluate Monotherapy Compared to Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This Randomized Phase 3 Open-label Study will Evaluate the Efficacy of Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB154 in Front-Line, PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcus Biosciences, Inc.
• Treatments: Carboplatin; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Histologically confirmed, squamous or nonsquamous, treatment-naive PD-L1 positive, NSCLC that is locally advanced or metastatic without sensitizing epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• Must have at least 1 measurable lesion per RECIST v1.1

• Adequate organ and marrow function

Exclusion Criteria:

• Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available

• Use of any live vaccines against infectious diseases within 28 days of first dose

• Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.

• Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer

• Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.