drugset / Trial / NCT04984811
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | NT-I7 | Protein / enzyme biologic | 1200 ug/kg | Intramuscular |