NT-I7 + Atezolizumab for Lung Cancer

Recruiting at 22 trial locations

Overseen By Byung Ha Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NeoImmuneTech

Must not be taking: mAbs, IV immunoglobulin

Disqualifiers: EGFR, ALK, BRAF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: approximately 2 years

83 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NT-I7 IM on Day 1 and every 6 weeks and atezolizumab IV 1200 mg every 3 weeks until disease progression

approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Atezolizumab
• NT-I7

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.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

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