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NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
Sponsor: NeoImmuneTech
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2021-11-03
Completion Date
2025-03
Last Updated
2024-03-05
Healthy Volunteers
No
Conditions
Interventions
efineptakin alfa
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years).
Atezolizumab
1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years).
Locations (22)
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
St. 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