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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04984811
• Other study ID #: NIT-119
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 3, 2021
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: NeoImmuneTech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Non-Small Cell Lung Cancer
• Non-Small Cell Lung Carcinoma
• Nonsmall Cell Lung Cancer

Intervention

Drug:
• efineptakin alfa
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
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).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
NeoImmuneTech	Roche Pharma AG

Country where clinical trial is conducted

United States, 

Outcome

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