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

# NCT04262856 Trial phase: 2 Overall status: Recruiting Study type: immunotherapy, targeted

Study Start Date

May, 2020

Scientific Title

A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer


This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, locally advanced or metastatic non-small cell lung cancer.

- Male or female participants; age ≥ 18 years - Histologically confirmed squamous or nonsquamous, PD-L1 positive, NSCLC that is locally advanced or metastatic without sensitizing epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation expression - 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

- Use of any live vaccines against infectious diseases within 28 days of first dose - Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications - Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody or Hepatitis C qualitative RNA or human immunodeficiency virus-1 (HIV-1) antibody - 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

Study Design

Primary purpose: Treatment , Allocation: Randomized , Intervention model: Parallel Assignment , Masking: None (Open Label),


Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer, Non Small Cell Lung Cancer, Lung Cancer

Other Study ID Numbers



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