NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedefineptakin alfa and Atezolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 11, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?22 U.S. locations

Locations may change over time.

Who runs it?NeoImmuneTech

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: NeoImmuneTech
Interventions being studied: Drug: efineptakin alfa; Drug: Atezolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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