NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
Megadott ok: 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 és West Palm Beach, Egyesült ÁllamokSee the 22 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- University Cancer and Blood CenterAthens, Egyesült ÁllamokNo longer taking part
- TOI Clinical ResearchCerritos, Egyesült ÁllamokNo longer taking part
- Tennessee Oncology - ChattanoogaChattanooga, Egyesült ÁllamokNo longer taking part
- Zangmeister Cancer CenterColumbus, Egyesült ÁllamokNo longer taking part
- Renovatio Clinical - El PasoEl Paso, Egyesült ÁllamokNo longer taking part
- Summit Health Medical CenterFlorham Park, Egyesült ÁllamokNo longer taking part
- Florida Cancer Specialists - South Research OfficeFort Myers, Egyesült ÁllamokNo longer taking part
- Goshen Center for Cancer CareGoshen, Egyesült ÁllamokNo longer taking part
- East Carolina UniversityGreenville, Egyesült ÁllamokNo longer taking part
- Thompson Cancer Survival CenterKnoxville, Egyesült ÁllamokNo longer taking part
- Norton Cancer InstituteLouisville, Egyesült ÁllamokNo longer taking part
- University of South AlabamaMobile, Egyesült ÁllamokNo longer taking part
- Tennessee Oncology - NashvilleNashville, Egyesült ÁllamokNo longer taking part
- Eastern CT Hematology & Oncology AssociatesNorwich, Egyesült ÁllamokNo longer taking part
- Pikeville Medical Center, Inc.Pikeville, Egyesült ÁllamokNo longer taking part
- BRCR Medical CenterPlantation, Egyesült ÁllamokNo longer taking part
- OHSU Knight Cancer InstitutePortland, Egyesült ÁllamokNo longer taking part
- TidalHealth Peninsula Regional, Inc.Salisbury, Egyesült ÁllamokNo longer taking part
- MaineHealth Cancer CareSouth Portland, Egyesült ÁllamokNo longer taking part
- Florida Cancer Specialists - North Research OfficeSt. Petersburg, Egyesült ÁllamokNo longer taking part
- Renovatio Clinical - The WoodlandsThe Woodlands, Egyesült ÁllamokNo longer taking part
- Florida Cancer Specialists - East Research OfficeWest Palm Beach, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- NeoImmuneTech
- Trial code
- NCT04984811
- Record updated
- 2026. június 11.
- 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.