NT-I7 + Atezolizumab for Lung Cancer

Not currently recruiting at 23 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two treatments, NT-I7 (a new potential drug) and atezolizumab (an immunotherapy drug), to evaluate their effectiveness in fighting lung cancer. It specifically targets individuals with advanced non-small cell lung cancer (NSCLC) that has not been treated before and shows a certain protein (PD-L1) on their tumor cells. The trial aims to determine if these treatments can effectively control or reduce the tumor. Suitable candidates for this trial are those with advanced lung cancer who have not received any cancer treatments and whose cancer exhibits specific markers. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining NT-I7 with atezolizumab was safe in earlier studies. Most patients tolerated the treatment well, experiencing manageable side effects without unexpected negative reactions. This suggests the treatment might be safe for individuals with advanced lung cancer.

Atezolizumab, already approved by the FDA for certain cancers, has a well-established safety profile. When combined with NT-I7, it has been tested in patients with other cancers and was found to be safe. Although all treatments can have side effects, current evidence suggests this combination is relatively safe. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for lung cancer?

Researchers are excited about the combination of NT-I7 and atezolizumab for lung cancer because it offers a fresh approach to treatment. Unlike standard therapies for non-small cell lung cancer (NSCLC) that often rely solely on checkpoint inhibitors like atezolizumab, this treatment adds NT-I7, an innovative agent designed to boost the immune system by increasing T-cell counts. The combination aims to enhance the body's natural defenses to attack cancer cells more effectively, potentially leading to better outcomes for patients with advanced NSCLC.

What evidence suggests that NT-I7 and atezolizumab could be effective for lung cancer?

In this trial, participants will receive a combination of NT-I7 and atezolizumab. Research shows that NT-I7, also known as efineptakin alfa, can extend the lifespan of mice with tumors by boosting immune cells like T and B cells, which fight cancer. In some human studies, NT-I7 has shown promise in enhancing the effectiveness of other cancer treatments. Atezolizumab is a well-researched treatment for non-small cell lung cancer (NSCLC). It has helped patients with advanced NSCLC live longer, with one study reporting an average survival time of 19.2 months. Together, NT-I7 and atezolizumab aim to enhance the body's immune response against lung cancer, offering hope for better patient outcomes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9716834/

updated long-term efficacy of atezolizumab in a diverse ... In patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), atezolizumab therapy improves survival with manageable safety.

2. tecentriq.com tecentriq.com/metastatic-nsclc/results/how-tecentriq-may-help.html

Effectiveness & Safety of TECENTRIQ® (atezolizumab) for ... Median overall survival (OS) was 19.2 months for patients taking TECENTRIQ® (atezolizumab. Median OS=the length of time from the start of treatment in a ...

3. tecentriq-hcp.com tecentriq-hcp.com/adjuvant-nsclc/efficacy/primary-endpoint.html

TECENTRIQ ® (atezolizumab) DFS results in IMpower010 At primary DFS analysis: 34% reduced risk of relapse demonstrated with TECENTRIQ vs BSC in PD-L1+ stage II-IIIA NSCLC · At final DFS analysis: Median DFS for ...

4. tecentriq.com tecentriq.com/nsclc-after-surgery/results/how-tecentriq-may-help.html

TECENTRIQ may prevent your PD-L1+ non-small cell lung ... TECENTRIQ may prevent your PD-L1+ non-small cell lung cancer from coming back · More people were alive with TECENTRIQ than with best supportive care · Important ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9253603/

Efficacy of Atezolizumab for Advanced Non-Small Cell ... The comprehensive results showed that atezolizumab substantially enhanced OS (HR 0.82; 95% CI, 0.77–0.88; p < 0.00001) (Figure 3A).

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.9561

A phase 1b/2a study of safety and efficacy of NT-I7 in ... This is a phase 1b/2a study to evaluate the safety and efficacy of NT-I7 in combination with atezo in pts with CPI- naïve or relapsed/refractory (R/R) high- ...

7. clinconnect.io clinconnect.io/trials/NCT04984811

NT-I7 in Combination With Atezolizumab in Previously 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 ...

8. clin.larvol.com clin.larvol.com/trial/NCT04984811

NT-I7 in Combination With Atezolizumab in Previously ... Businesswire 2021 - NeoImmuneTech Announces First Patient Dosed in Phase 2 Study of NT-I7 (efineptakin alfa) in Combination with PD-L1 Checkpoint Inhibitor ...

9. researchgate.net researchgate.net/publication/361129595_A_phase_1b2a_study_of_safety_and_efficacy_of_NT-I7_in_combination_with_anti-PD-L1_atezolizumab_in_patients_with_anti-PD-1PD-L1_naive_or_relapsedrefractory_RR_high-risk_skin_cancers_The_phase_1b_report

A phase 1b/2a study of safety and efficacy of NT-I7 in ... NT-I7 in combination with atezolizumab (atezo), may augment the efficacy in high-risk skin cancers. Methods: This is a phase 1b/2a study to ...

10. prnewswire.com prnewswire.com/news-releases/neoimmunetechs-lead-asset-nt-i7-efineptakin-alfa-shows-preliminary-anticancer-activity-in-combination-with-check-point-inhibitors-301561683.html

NeoImmuneTech's Lead Asset NT-I7 (efineptakin alfa) ... In the phase 1b/2a study NIT-106, the combination of NT-I7 with atezolizumab showed favorable safety and anticancer activity in CPI-relapsed/ ...