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

NCT04984811 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NIT-119
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 22

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Nonsmall Cell Lung Cancer; Non-Small Cell Lung Carcinoma; 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Duration of response (DoR)

  approximately 2 years

• Disease Control Rate (DCR)

  approximately 2 years

• Progression Free Survival (PFS)

  approximately 2 years

• Overall survival (OS)

  approximately 2 years

Study Arms (1)

NT-I7 and atezolizumab

EXPERIMENTAL

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.

Drug: efineptakin alfa; Drug: Atezolizumab

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).

Also known as: NT-I7

NT-I7 and atezolizumab

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).

Also known as: Tecentriq

NT-I7 and atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeoImmuneTech: lead
• Roche Pharma AG: collaborator

Study Sites (22)

University of South Alabama

Mobile, Alabama, 36604, United States

Location

TOI Clinical Research

Cerritos, California, 90703, United States

Location

Eastern CT Hematology & Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Florida Cancer Specialists - South Research Office

Fort Myers, Florida, 33916, United States

Location

BRCR Medical Center

Plantation, Florida, 33322, United States

Location

Florida Cancer Specialists - North Research Office

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists - East Research Office

West Palm Beach, Florida, 33401, United States

Location

University Cancer and Blood Center

Athens, Georgia, 30607, United States

Location

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40217, United States

Location

Pikeville Medical Center, Inc.

Pikeville, Kentucky, 41501, United States

Location

MaineHealth Cancer Care

South Portland, Maine, 04106, United States

Location

TidalHealth Peninsula Regional, Inc.

Salisbury, Maryland, 21801, United States

Location

Summit Health Medical Center

Florham Park, New Jersey, 07932, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Zangmeister Cancer Center

Columbus, Ohio, 43219, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Tennessee Oncology - Nashville

Nashville, Tennessee, 37203, United States

Location

Renovatio Clinical - El Paso

El Paso, Texas, 79915, United States

Location

Renovatio Clinical - The Woodlands

The Woodlands, Texas, 77380, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

efineptakin alfa; atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 2, 2021
• Study Start: November 3, 2021
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

US (22)