NT-I7 + Atezolizumab for Lung Cancer

Recruiting at 22 trial locations

Overseen By Byung Ha Lee, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NeoImmuneTech

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with a type of lung cancer called NSCLC that shows PD-L1 expression and hasn't spread too far. They should be fairly fit (ECOG 0-1), have not had previous systemic treatments, and can't be candidates for surgery or definitive chemoradiation if their disease is locally advanced.

Inclusion Criteria

My lung cancer is advanced but hasn't been treated with systemic therapy yet.

My cancer can be measured by tests.

My tumor shows PD-L1 expression of 1% or more.

Exclusion Criteria

I have not had radiotherapy in the last 2 weeks.

You have had serious reactions to certain types of medications given through an IV.

You have had an autoimmune disease in the past two years.

Treatment Details

Interventions

• Atezolizumab (Checkpoint Inhibitor)
• NT-I7 (Cytokine)

Trial Overview The study tests NT-I7 combined with Atezolizumab in patients to see how well it works against this lung cancer. It's an open-label Phase II trial, meaning both researchers and participants know what treatment is being given.

Participant Groups

Group I: NT-I7 and atezolizumab Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

NeoImmuneTech

Lead Sponsor

Trials

16

Recruited

780+

Roche Pharma AG

Industry Sponsor

Trials

413

Recruited

430,000+

Dr. Thomas Schinecker

Roche Pharma AG

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Dr. Levi Garraway

Roche Pharma AG

Chief Medical Officer since 2019

MD from University of California, San Francisco