NCT04984811

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: NeoImmuneTech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).
DRUG	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).

Timeline

• Start date: 2021-11-03
• Primary completion: 2024-09-01
• Completion: 2025-03-01
• First posted: 2021-08-02
• Last updated: 2024-03-05

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study