drugset / Trial / NCT04984811

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

NCT04984811

Phase 2 Terminated 33 enrolled NeoImmuneTech Roche Pharma AG · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-11-15
Primary completion
2024-08-28
Completion
2024-09-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject NT-I7 Protein / enzyme biologic 1200 ug/kg Intramuscular