What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and chemotherapy. Immune checkpoint inhibitors such as pembrolizumab, nivolumab, and atezolizumab can cause immune-related side effects like pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy agents like carboplatin, paclitaxel, and pemetrexed are associated with side effects including nausea, vomiting, myelosuppression, neuropathy, and fatigue. Combining these treatments can increase the risk of severe adverse events, including pneumonia, febrile neutropenia, and organ-specific toxicities.

What prior FDA approvals exist?

Several immunotherapy drugs have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab (Keytruda) is approved for use in combination with chemotherapy for first-line treatment of metastatic NSCLC and as monotherapy for tumors with high PD-L1 expression. Nivolumab (Opdivo) is approved for previously treated advanced NSCLC. Atezolizumab (Tecentriq) is approved for metastatic NSCLC following platinum-based chemotherapy. Cemiplimab (Libtayo) is approved for first-line treatment of advanced NSCLC with high PD-L1 expression. These drugs enhance the immune response by targeting PD-1 or PD-L1 pathways, similar to the mechanism of action being studied with the IL-15 Superagonist in the N-803 trial.

What other types of research exist?

Promising novel alternatives to N-803 for NSCLC patients include: 1) Pembrolizumab plus chemotherapy, which has shown improved overall survival and progression-free survival in advanced NSCLC. 2) Nivolumab plus ipilimumab, which has demonstrated efficacy in various trials for advanced NSCLC. 3) Atezolizumab in combination with chemotherapy, particularly for patients with high PD-L1 expression. These treatments have shown significant benefits in clinical trials and are likely to be relevant options in 2024.

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Alkylating agents

N-803 + Standard Care for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by ImmunityBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject's tumor must not harbor an EGFR sensitizing (activating) mutation or ALK translocation or targetable genomic aberration in BRAF, ROS1 or NTRK

Histologically-confirmed stage 3 or 4 NSCLC disease. Subjects with stage 3 disease must not be candidates for treatment with surgical resection or chemoradiation

Must not have

History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroid use to manage AEs are permitted

History of human immunodeficiency virus (HIV), or known active hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests N-803 with standard treatments for patients with severe lung cancer. N-803 aims to boost the immune system to fight cancer cells more effectively.

Who is the study for?

This trial is for adults with stage 3 or 4 non-small cell lung cancer (NSCLC) who haven't had systemic chemotherapy for advanced/metastatic NSCLC. They must have tumors without certain genetic mutations, measurable tumor lesions, and an ECOG performance status of 0 or 1. Participants need to provide consent, tissue samples, agree to contraception use if applicable, and not be candidates for surgery or chemoradiation.

What is being tested?

The study compares the safety and effectiveness of N-803 combined with standard cancer treatments versus the standard treatments alone in NSCLC patients. It's a phase 3 trial where treatment continues up to two years unless there are issues like disease progression or unacceptable side effects.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drugs being administered intravenously, fatigue from treatment burden on the body, digestive disturbances due to drug impact on gastrointestinal function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor does not have specific genetic changes in EGFR, ALK, BRAF, ROS1, or NTRK.

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My lung cancer is at stage 3 or 4 and cannot be treated with surgery or chemoradiation.

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I am 18 years old or older.

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I agree to use effective birth control during and after the treatment.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant, lung issues needing steroids, or took immunosuppressants recently.

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I have a history of HIV or active hepatitis B or C.

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I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.

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My lab results show my organs are not functioning well.

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I need oxygen all the time due to my advanced cancer.

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I haven't been in a drug study or taken experimental treatments in the last 30 days, except for testosterone-lowering therapy.

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I haven't had chemotherapy, major surgery, or chest radiation in the last 3 weeks.

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I am currently pregnant or nursing.

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I have a systemic autoimmune disease like lupus or rheumatoid arthritis.

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I am currently on IV antibiotics for an infection.

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I am not taking any medications that react badly with the study drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DOR)

Overall Response Rate (ORR)

+2 more

Other study objectives

Immunogenicity profile of N-803 in combination with pembrolizumab (Cohorts A, B, C only).

Incidence of treatment-emergent AEs and SAEs

Tumor molecular profiles and correlations with subject outcomes (Cohorts A, B, C only).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Cohort D (Experimental)Experimental Treatment1 Intervention

Group II: Cohort C (Experimental)Experimental Treatment1 Intervention

Group III: Cohort B (Experimental)Experimental Treatment1 Intervention

Group IV: Cohort A (Experimental)Experimental Treatment1 Intervention

Group V: Cohort A (Control)Active Control1 Intervention

Group VI: Cohort B (Control)Active Control1 Intervention

Group VII: Cohort C (Control)Active Control1 Intervention

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy and chemotherapy. Immunotherapy, such as immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab), enhances the immune system's ability to target and destroy cancer cells by blocking proteins that inhibit T-cell activity. Chemotherapy uses drugs like cisplatin and pemetrexed to kill cancer cells by damaging their DNA or disrupting cell division. The IL-15 superagonist (N-803) being studied aims to further boost the immune response by enhancing the activity of natural killer (NK) cells and T-cells. This is crucial for NSCLC patients as it may improve the body's natural ability to combat cancer, potentially leading to better outcomes and prolonged survival.