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

Who is this study for? Patients with previously untreated, PD-L1-expressing, locally advanced or metastatic NSCLC
What treatments are being studied? Efineptakin alfa+Atezolizumab
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Alabama
University of South Alabama
Not yet recruiting
Mobile
California
Innovative Clinical Research Institute (ICRI)
Recruiting
Whittier
Connecticut
Eastern CT Hematology & Oncology Associates
Withdrawn
Norwich
Florida
Florida Cancer Specialists - South Research Office
Recruiting
Fort Myers
BRCR Medical Center
Recruiting
Plantation
Florida Cancer Specialists - North Research Office
Recruiting
Saint Petersburg
Florida Cancer Specialists - East Research Office
Recruiting
West Palm Beach
Georgia
University Cancer and Blood Center
Not yet recruiting
Athens
Kentucky
Norton Cancer Institute
Not yet recruiting
Louisville
Louisiana
Hematology Oncology Clinic
Recruiting
Baton Rouge
Ohio
Zangmeister Cancer Center
Recruiting
Columbus
Oregon
OHSU Knight Cancer Institute
Recruiting
Portland
Tennessee
Tennessee Oncology - Chattanooga
Recruiting
Chattanooga
Thompson Cancer Survival Center
Recruiting
Knoxville
Tennessee Oncology - Nashville
Recruiting
Nashville
Contact Information
Primary
Jean Fan, MD
NIT119@neoimmunetech.com; jfan@neoimmunetech.com
301-337-2283
Time Frame
Start Date: November 3, 2021
Estimated Completion Date: June 2024
Participants
Target number of participants: 83
Treatments
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.
Sponsors
Collaborators: Roche Pharma AG
Leads: NeoImmuneTech

This content was sourced from clinicaltrials.gov

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