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

Stopped early · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT04984811

Run by

NeoImmuneTech

People needed

33

Starts

2021-11-15

Expected to finish

2024-09-19

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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