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Brief Title: NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
Official Title: A Multicenter, Open-label, Single-arm Phase II Study to Evaluate Anti-tumor Efficacy and Safety of NT-I7 in Combination With Atezolizumab in Subjects With Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
Study ID: NCT04984811
Brief Summary: This is a multicenter, open-label, single-arm Phase II study to evaluate anti-tumor efficacy and safety of NT-I7 in combination with atezolizumab in subjects with PD-L1-expressing (TPS ≥ 1%), metastatic (Stage IV) or locally advanced squamous or non-squamous NSCLC who have not received prior systemic therapy in the metastatic or locally advanced setting. Eligible subjects must have measurable disease according to RECIST 1.1. This Phase II study will enroll up to 83 subjects.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of South Alabama, Mobile, Alabama, United States
TOI Clinical Research, Cerritos, California, United States
Eastern CT Hematology & Oncology Associates, Norwich, Connecticut, United States
Florida Cancer Specialists - South Research Office, Fort Myers, Florida, United States
BRCR Medical Center, Plantation, Florida, United States
Florida Cancer Specialists - North Research Office, Saint Petersburg, Florida, United States
Florida Cancer Specialists - East Research Office, West Palm Beach, Florida, United States
University Cancer and Blood Center, Athens, Georgia, United States
Goshen Center for Cancer Care, Goshen, Indiana, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Pikeville Medical Center, Inc., Pikeville, Kentucky, United States
MaineHealth Cancer Care, South Portland, Maine, United States
TidalHealth Peninsula Regional, Inc., Salisbury, Maryland, United States
Summit Health Medical Center, Florham Park, New Jersey, United States
East Carolina University, Greenville, North Carolina, United States
Zangmeister Cancer Center, Columbus, Ohio, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
Tennessee Oncology - Chattanooga, Chattanooga, Tennessee, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Tennessee Oncology - Nashville, Nashville, Tennessee, United States
Renovatio Clinical - El Paso, El Paso, Texas, United States
Renovatio Clinical - The Woodlands, The Woodlands, Texas, United States