NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC

Part of paid clinical trials in Mobile, Alabama.

Sponsor
NeoImmuneTech
Study ID
NCT04984811
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efineptakin alfa — DRUG
    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).
  • Atezolizumab — DRUG
    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).

Study Details

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.

Key Dates

Start date
Nov 15, 2021
Status verified
May 2026
Primary completion
Aug 28, 2024
Completion
Sep 19, 2024

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 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). ]

Locations (22)

FacilityCityStateZIPSite coordinators
University of South AlabamaMobileAlabama36604-
TOI Clinical ResearchCerritosCalifornia90703-
Eastern CT Hematology & Oncology AssociatesNorwichConnecticut06360-
Florida Cancer Specialists - South Research OfficeFort MyersFlorida33916-
BRCR Medical CenterPlantationFlorida33322-
Florida Cancer Specialists - North Research OfficeSt. PetersburgFlorida33705-
Florida Cancer Specialists - East Research OfficeWest Palm BeachFlorida33401-
University Cancer and Blood CenterAthensGeorgia30607-
Goshen Center for Cancer CareGoshenIndiana46526-
Norton Cancer InstituteLouisvilleKentucky40217-
Pikeville Medical Center, Inc.PikevilleKentucky41501-
MaineHealth Cancer CareSouth PortlandMaine04106-
TidalHealth Peninsula Regional, Inc.SalisburyMaryland21801-
Summit Health Medical CenterFlorham ParkNew Jersey07932-
East Carolina UniversityGreenvilleNorth Carolina27834-
Zangmeister Cancer CenterColumbusOhio43219-
OHSU Knight Cancer InstitutePortlandOregon97239-
Tennessee Oncology - ChattanoogaChattanoogaTennessee37404-
Thompson Cancer Survival CenterKnoxvilleTennessee37916-
Tennessee Oncology - NashvilleNashvilleTennessee37203-
Renovatio Clinical - El PasoEl PasoTexas79915-
Renovatio Clinical - The WoodlandsThe WoodlandsTexas77380-

Find similar trials in Mobile, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of South Alabama· Mobile, ALTOI Clinical Research· Cerritos, CAEastern CT Hematology & Oncology Associates· Norwich, CTFlorida Cancer Specialists - South Research Office· Fort Myers, FLBRCR Medical Center· Plantation, FLFlorida Cancer Specialists - North Research Office· St. Petersburg, FL

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