- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04984811
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
March 3, 2024 updated by: NeoImmuneTech
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
83
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Byung Ha Lee, PhD
- Phone Number: 240-801-9069
- Email: NIT119@neoimmunetech.com; blee@neoimmunetech.com
Study Locations
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Alabama
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Mobile, Alabama, United States, 36604
- University of South Alabama
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California
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Cerritos, California, United States, 90703
- TOI Clinical Research
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Connecticut
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Norwich, Connecticut, United States, 06360
- Eastern CT Hematology & Oncology Associates
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Florida
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Fort Myers, Florida, United States, 33916
- Florida Cancer Specialists - South Research Office
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Plantation, Florida, United States, 33322
- BRCR Medical Center
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Saint Petersburg, Florida, United States, 33705
- Florida Cancer Specialists - North Research Office
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West Palm Beach, Florida, United States, 33401
- Florida Cancer Specialists - East Research Office
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Georgia
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Athens, Georgia, United States, 30607
- University Cancer and Blood Center
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Indiana
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Goshen, Indiana, United States, 46526
- Goshen Center for Cancer Care
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Kentucky
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Louisville, Kentucky, United States, 40217
- Norton Cancer Institute
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Pikeville, Kentucky, United States, 41501
- Pikeville Medical Center, Inc.
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Maine
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South Portland, Maine, United States, 04106
- MaineHealth Cancer Care
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Maryland
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Salisbury, Maryland, United States, 21801
- TidalHealth Peninsula Regional, Inc.
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New Jersey
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Florham Park, New Jersey, United States, 07932
- Summit Health Medical Center
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North Carolina
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Greenville, North Carolina, United States, 27834
- East Carolina University
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Ohio
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Columbus, Ohio, United States, 43219
- Zangmeister Cancer Center
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Oregon
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Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Tennessee Oncology - Chattanooga
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Knoxville, Tennessee, United States, 37916
- Thompson Cancer Survival Center
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Nashville, Tennessee, United States, 37203
- Tennessee Oncology - Nashville
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Texas
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El Paso, Texas, United States, 79915
- Renovatio Clinical - El Paso
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The Woodlands, Texas, United States, 77380
- Renovatio Clinical - The Woodlands
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NT-I7 and atezolizumab
Participants 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.
|
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).
Other Names:
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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: approximately 2 years
|
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.
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approximately 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: approximately 2 years
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The time from first study treatment (Cycle 1, Day 1) to death from any cause.
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approximately 2 years
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Duration of response (DoR)
Time Frame: approximately 2 years
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Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator.
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approximately 2 years
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Disease Control Rate (DCR)
Time Frame: approximately 2 years
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The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 and iRECIST as determined by the investigator.
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approximately 2 years
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Progression Free Survival (PFS)
Time Frame: approximately 2 years
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The time from the first study treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator.
|
approximately 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2021
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
July 14, 2021
First Submitted That Met QC Criteria
July 29, 2021
First Posted (Actual)
August 2, 2021
Study Record Updates
Last Update Posted (Actual)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 3, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Atezolizumab
Other Study ID Numbers
- NIT-119
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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