Study Stopped
sponsor decision (not for safety)
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
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
1 other identifier
interventional
33
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2021
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2021
CompletedFirst Posted
Study publicly available on registry
August 2, 2021
CompletedStudy Start
First participant enrolled
November 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2024
CompletedResults Posted
Study results publicly available
June 11, 2026
CompletedJune 11, 2026
May 1, 2026
2.8 years
July 14, 2021
November 17, 2025
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1.
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Secondary Outcomes (4)
Duration of Response (DoR)
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Disease Control Rate (DCR)
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Progression Free Survival (PFS)
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Overall Survival (OS)
Up to 2 years
Study Arms (1)
NT-I7 and atezolizumab
EXPERIMENTALParticipants with no prior systemic therapy for advanced NSCLC will receive 1200 μg/kg NT-I7 IM on Day 1 and every 6 weeks and atezolizumab IV 1200 mg every 3 weeks until disease progression.
Interventions
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years).
1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. The treatment will be continued up to a maximum of 35 cycles (approximately 2 years).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeoImmuneTechlead
- Roche Pharma AGcollaborator
Study Sites (22)
University of South Alabama
Mobile, Alabama, 36604, United States
TOI Clinical Research
Cerritos, California, 90703, United States
Eastern CT Hematology & Oncology Associates
Norwich, Connecticut, 06360, United States
Florida Cancer Specialists - South Research Office
Fort Myers, Florida, 33916, United States
BRCR Medical Center
Plantation, Florida, 33322, United States
Florida Cancer Specialists - North Research Office
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - East Research Office
West Palm Beach, Florida, 33401, United States
University Cancer and Blood Center
Athens, Georgia, 30607, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Norton Cancer Institute
Louisville, Kentucky, 40217, United States
Pikeville Medical Center, Inc.
Pikeville, Kentucky, 41501, United States
MaineHealth Cancer Care
South Portland, Maine, 04106, United States
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21801, United States
Summit Health Medical Center
Florham Park, New Jersey, 07932, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Zangmeister Cancer Center
Columbus, Ohio, 43219, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, 37404, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
Renovatio Clinical - El Paso
El Paso, Texas, 79915, United States
Renovatio Clinical - The Woodlands
The Woodlands, Texas, 77380, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Young Joo (Paul) Kim
- Organization
- NeoImmuneTech, Inc.
Study Officials
- STUDY CHAIR
Donghoon Choi, PhD
NeoImmuneTech
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2021
First Posted
August 2, 2021
Study Start
November 15, 2021
Primary Completion
August 28, 2024
Study Completion
September 19, 2024
Last Updated
June 11, 2026
Results First Posted
June 11, 2026
Record last verified: 2026-05