NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Carcinoma, Non-Small-Cell Lung,Non-Small Cell Lung Cancer,Non-Small Cell Lung Carcinoma,Nonsmall Cell Lung Cancer,Non Small Cell Lung Cancer
Age (in years)
18+
Phase
Phase 2
Participants needed
83
Est. Completion Date
Mar 31, 2025
Treatment type
Interventional
Sponsor
NeoImmuneTech
ClinicalTrials.gov identifier
NCT04984811
Study number
NIT-119
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?