Clinical trial NCT04984811: NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Non-Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Nonsmall Cell Lung Cancer
Non Small Cell Lung Cancer
Keywords: Advanced
Metastatic
NSCLC
PD-L1
Atezolizumab
NT-I7
Non Small Cell Lung Cancer
Non-small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Nonsmall Cell Lung Cancer
efineptakin alfa
efineptakin
Lead sponsor: NeoImmuneTech
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2021-08-02
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: approximately 2 years
Secondary outcomes:
measure: Duration of response (DoR)
timeFrame: approximately 2 years
measure: Disease Control Rate (DCR)
timeFrame: approximately 2 years
measure: Progression Free Survival (PFS)
timeFrame: approximately 2 years
measure: Overall survival (OS)
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Cerritos
country: United States
facility: TOI Clinical Research
state: California
city: Norwich
country: United States
facility: Eastern CT Hematology & Oncology Associates
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South Research Office
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North Research Office
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East Research Office
state: Florida
city: Athens
country: United States
facility: University Cancer and Blood Center
state: Georgia
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Pikeville
country: United States
facility: Pikeville Medical Center, Inc.
state: Kentucky
city: South Portland
country: United States
facility: MaineHealth Cancer Care
state: Maine
city: Salisbury
country: United States
facility: TidalHealth Peninsula Regional, Inc.
state: Maryland
city: Florham Park
country: United States
facility: Summit Health Medical Center
state: New Jersey
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Columbus
country: United States
facility: Zangmeister Cancer Center
state: Ohio
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Chattanooga
country: United States
facility: Tennessee Oncology - Chattanooga
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology - Nashville
state: Tennessee
city: El Paso
country: United States
facility: Renovatio Clinical - El Paso
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical - The Woodlands
state: Texas
Study officials:
References: