NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
- Conditions
- Non Small Cell Lung CancerNon-Small Cell Lung CarcinomaCarcinoma, Non-Small-Cell LungNon-Small Cell Lung CancerNonsmall Cell Lung Cancer
- Interventions
- Registration Number
- NCT04984811
- Lead Sponsor
- NeoImmuneTech
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 83
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NT-I7 and atezolizumab 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. NT-I7 and atezolizumab efineptakin alfa 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 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.
- Secondary Outcome Measures
Name Time Method Duration of response (DoR) approximately 2 years 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.
Overall survival (OS) approximately 2 years The time from first study treatment (Cycle 1, Day 1) to death from any cause.
Progression Free Survival (PFS) approximately 2 years 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.
Disease Control Rate (DCR) approximately 2 years 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.
Trial Locations
- Locations (22)
Zangmeister Cancer Center
🇺🇸Columbus, Ohio, United States
Tennessee Oncology - Nashville
🇺🇸Nashville, Tennessee, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
TOI Clinical Research
🇺🇸Cerritos, California, 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
🇺🇸Saint Petersburg, Florida, United States
Eastern CT Hematology & Oncology Associates
🇺🇸Norwich, Connecticut, United States
Florida Cancer Specialists - East Research Office
🇺🇸West Palm Beach, Florida, United States
University Cancer and Blood Center
🇺🇸Athens, Georgia, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Goshen Center for Cancer Care
🇺🇸Goshen, Indiana, United States
MaineHealth Cancer Care
🇺🇸South Portland, Maine, United States
Pikeville Medical Center, Inc.
🇺🇸Pikeville, Kentucky, United States
TidalHealth Peninsula Regional, Inc.
🇺🇸Salisbury, Maryland, United States
Summit Health Medical Center
🇺🇸Florham Park, New Jersey, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
OHSU Knight Cancer Institute
🇺🇸Portland, Oregon, United States
Tennessee Oncology - Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Renovatio Clinical - The Woodlands
🇺🇸The Woodlands, Texas, United States
Renovatio Clinical - El Paso
🇺🇸El Paso, Texas, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States