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

Phase 2

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Nonsmall Cell Lung Cancer
• Interventions: Drug: efineptakin alfa; Drug: Atezolizumab

• Registration Number: NCT04984811
• Lead Sponsor: NeoImmuneTech

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-02
• Study Start: 2021-11-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NT-I7 and atezolizumab	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.
NT-I7 and atezolizumab	efineptakin alfa	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 Measures

Name	Time	Method
Objective Response Rate (ORR)	approximately 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	approximately 2 years	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.
Overall survival (OS)	approximately 2 years	The time from first study treatment (Cycle 1, Day 1) to death from any cause.
Progression Free Survival (PFS)	approximately 2 years	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.
Disease Control Rate (DCR)	approximately 2 years	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.

Trial Locations

Locations (22)

Zangmeister Cancer Center; 🇺🇸 Columbus, Ohio, United States

Tennessee Oncology - Nashville; 🇺🇸 Nashville, Tennessee, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

TOI Clinical Research; 🇺🇸 Cerritos, California, United States

Florida Cancer Specialists - South Research Office; 🇺🇸 Fort Myers, Florida, United States

BRCR Medical Center; 🇺🇸 Plantation, Florida, United States

Florida Cancer Specialists - North Research Office; 🇺🇸 Saint Petersburg, Florida, United States

Eastern CT Hematology & Oncology Associates; 🇺🇸 Norwich, Connecticut, United States

Florida Cancer Specialists - East Research Office; 🇺🇸 West Palm Beach, Florida, United States

University Cancer and Blood Center; 🇺🇸 Athens, Georgia, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Goshen Center for Cancer Care; 🇺🇸 Goshen, Indiana, United States

MaineHealth Cancer Care; 🇺🇸 South Portland, Maine, United States

Pikeville Medical Center, Inc.; 🇺🇸 Pikeville, Kentucky, United States

TidalHealth Peninsula Regional, Inc.; 🇺🇸 Salisbury, Maryland, United States

Summit Health Medical Center; 🇺🇸 Florham Park, New Jersey, United States

Thompson Cancer Survival Center; 🇺🇸 Knoxville, Tennessee, United States

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

Tennessee Oncology - Chattanooga; 🇺🇸 Chattanooga, Tennessee, United States

Renovatio Clinical - The Woodlands; 🇺🇸 The Woodlands, Texas, United States

Renovatio Clinical - El Paso; 🇺🇸 El Paso, Texas, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States