NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
Reason given: sponsor decision (not for safety)
Key facts
- Where
- Athens, Cerritos, Chattanooga, Columbus, El Paso, Florham Park, Fort Myers, Goshen, Greenville, Knoxville, Louisville, Mobile, Nashville, Norwich, Pikeville, Plantation, Portland, Salisbury, South Portland, St. Petersburg, The Woodlands, and West Palm Beach, United StatesSee the 22 sites
- Phase
- Phase 2
Where in United States
- University Cancer and Blood CenterAthens, United StatesNo longer taking part
- TOI Clinical ResearchCerritos, United StatesNo longer taking part
- Tennessee Oncology - ChattanoogaChattanooga, United StatesNo longer taking part
- Zangmeister Cancer CenterColumbus, United StatesNo longer taking part
- Renovatio Clinical - El PasoEl Paso, United StatesNo longer taking part
- Summit Health Medical CenterFlorham Park, United StatesNo longer taking part
- Florida Cancer Specialists - South Research OfficeFort Myers, United StatesNo longer taking part
- Goshen Center for Cancer CareGoshen, United StatesNo longer taking part
- East Carolina UniversityGreenville, United StatesNo longer taking part
- Thompson Cancer Survival CenterKnoxville, United StatesNo longer taking part
- Norton Cancer InstituteLouisville, United StatesNo longer taking part
- University of South AlabamaMobile, United StatesNo longer taking part
- Tennessee Oncology - NashvilleNashville, United StatesNo longer taking part
- Eastern CT Hematology & Oncology AssociatesNorwich, United StatesNo longer taking part
- Pikeville Medical Center, Inc.Pikeville, United StatesNo longer taking part
- BRCR Medical CenterPlantation, United StatesNo longer taking part
- OHSU Knight Cancer InstitutePortland, United StatesNo longer taking part
- TidalHealth Peninsula Regional, Inc.Salisbury, United StatesNo longer taking part
- MaineHealth Cancer CareSouth Portland, United StatesNo longer taking part
- Florida Cancer Specialists - North Research OfficeSt. Petersburg, United StatesNo longer taking part
- Renovatio Clinical - The WoodlandsThe Woodlands, United StatesNo longer taking part
- Florida Cancer Specialists - East Research OfficeWest Palm Beach, United StatesNo longer taking part
Trial details
- Who runs it
- NeoImmuneTech
- Trial code
- NCT04984811
- Record updated
- 11 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Have histologically or cytologically confirmed metastatic or locally advanced NSCLC, and have not received prior systemic therapy. Subjects with locally advanced disease must have Stage III NSCLC and are not candidates for surgical resection or definitive chemoradiation; Tumor PD-L1 expression (TPS≥1%) as determined by PD-L1 22C3 immunohistochemistry local or central assay; Have measurable disease; Agree to provide screening biopsy (or archival tissue) at screening to assess PD-L1; ECOG 0-1; Adequate hematologic and end organ function.
Exclusion: Prior systemic anti-cancer therapy; Prior radiotherapy within 2 weeks of start of study treatment; Autoimmune disease history in past two years; NSCLC with EGFR, or ALK, or BRAF or ROS or RED or other genomic tumor aberrations which have available therapy; Known active CNS metastasis or carcinomatous meningitis; Severe reactions to mAbs or IV immunoglobulin preparations.