Non-Small Cell Lung Cancer Clinical Trial
Official title:
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
Verified date | March 2024 |
Source | NeoImmuneTech |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 83 |
Est. completion date | March 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University Cancer and Blood Center | Athens | Georgia |
United States | TOI Clinical Research | Cerritos | California |
United States | Tennessee Oncology - Chattanooga | Chattanooga | Tennessee |
United States | Zangmeister Cancer Center | Columbus | Ohio |
United States | Renovatio Clinical - El Paso | El Paso | Texas |
United States | Summit Health Medical Center | Florham Park | New Jersey |
United States | Florida Cancer Specialists - South Research Office | Fort Myers | Florida |
United States | Goshen Center for Cancer Care | Goshen | Indiana |
United States | East Carolina University | Greenville | North Carolina |
United States | Thompson Cancer Survival Center | Knoxville | Tennessee |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | University of South Alabama | Mobile | Alabama |
United States | Tennessee Oncology - Nashville | Nashville | Tennessee |
United States | Eastern CT Hematology & Oncology Associates | Norwich | Connecticut |
United States | Pikeville Medical Center, Inc. | Pikeville | Kentucky |
United States | BRCR Medical Center | Plantation | Florida |
United States | OHSU Knight Cancer Institute | Portland | Oregon |
United States | Florida Cancer Specialists - North Research Office | Saint Petersburg | Florida |
United States | TidalHealth Peninsula Regional, Inc. | Salisbury | Maryland |
United States | MaineHealth Cancer Care | South Portland | Maine |
United States | Renovatio Clinical - The Woodlands | The Woodlands | Texas |
United States | Florida Cancer Specialists - East Research Office | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
NeoImmuneTech | Roche Pharma AG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | approximately 2 years | |
Secondary | Duration of response (DoR) | 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. | approximately 2 years | |
Secondary | Disease Control Rate (DCR) | 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. | approximately 2 years | |
Secondary | Progression Free Survival (PFS) | 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 | |
Secondary | Overall survival (OS) | The time from first study treatment (Cycle 1, Day 1) to death from any cause. | approximately 2 years |
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