NT-I7 in Combination With Atezolizumab in 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.
Checked against the public recordLast updated Jun 11, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- NeoImmuneTech
- Interventions being studied
- Drug: efineptakin alfa; Drug: Atezolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Criteria: * Prior systemic anti-cancer therapy * NSCLC with EGFR, or ALK, or BRAF or ROS or RED or other genomic tumor aberrations which have available therapy * Prior radiotherapy within 2 weeks of start of study treatment * Known active CNS metastasis or carcinomatous meningitis * Severe reactions to mAbs or IV immunoglobulin preparations * Autoimmune disease history in past two years
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of South AlabamaMobile, Alabama
- TOI Clinical ResearchCerritos, California
- Eastern CT Hematology & Oncology AssociatesNorwich, Connecticut
- Florida Cancer Specialists - South Research OfficeFort Myers, Florida
- BRCR Medical CenterPlantation, Florida
- Florida Cancer Specialists - North Research OfficeSt. Petersburg, Florida
- Florida Cancer Specialists - East Research OfficeWest Palm Beach, Florida
- University Cancer and Blood CenterAthens, Georgia
- Goshen Center for Cancer CareGoshen, Indiana
- Norton Cancer InstituteLouisville, Kentucky
- Pikeville Medical Center, Inc.Pikeville, Kentucky
- MaineHealth Cancer CareSouth Portland, Maine
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 11, 2026. Always confirm current availability with the study team.