NK-102 + Atezolizumab for Lung Cancer

Overseen By Chao Family Comprehensive Cancer Center University of California, Irvine

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Irvine

Must not be taking: Antibiotics, Investigational agents

Disqualifiers: Active infection, Other active malignancy, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for individuals with advanced non-small cell lung cancer (NSCLC) who have previously tried treatments like PD-1 or PD-L1 inhibitors. The goal is to determine the highest safe dose of a new drug, NK-102 (experimental treatment), tested alone or with atezolizumab. Participants should have advanced NSCLC that continues to progress after prior treatments and should not have received any cancer therapy in the last three weeks. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that you have not had chemotherapy, radiation therapy, biological therapy, or immunotherapy within 21 days before starting the study treatment. It does not specify other medications, so you should discuss your current medications with the study team.

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

Research has shown that combining atezolizumab with other treatments has been explored in various studies. Atezolizumab, a drug that aids the immune system in fighting cancer, has generally been well-tolerated in past studies and has shown promising results in treating lung cancer when used with other therapies. However, since this is a Phase 1 trial for NK-102 and atezolizumab, the main goal is to determine the safety of NK-102 and identify the optimal dose. Phase 1 trials involve close monitoring to understand safety in humans, as this is one of the first steps in testing new treatments. While evidence suggests that atezolizumab is safe when combined with other drugs, the safety of NK-102 is still under investigation in this early phase. Participants in this trial will help researchers gather important safety information about using NK-102 with atezolizumab. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NK-102 combined with Atezolizumab for lung cancer because this combination takes a unique approach by harnessing the body's own immune system. Unlike traditional treatments such as chemotherapy and radiation that directly attack cancer cells, NK-102 is a natural killer (NK) cell therapy designed to enhance the immune system's ability to target and destroy cancer cells. When paired with Atezolizumab, an immune checkpoint inhibitor, this combination can potentially boost the immune response even further, offering a novel mechanism of action that might improve outcomes for patients with lung cancer. This dual approach could lead to more effective treatments and fewer side effects compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that atezolizumab, a type of immune therapy, helps people with advanced non-small cell lung cancer (NSCLC) by boosting the body's ability to find and fight cancer cells. Studies have found that combining atezolizumab with other treatments has led to promising survival rates. In this trial, participants will receive NK-102, which directly attacks and destroys cancer cells, either alone or with atezolizumab. Combining these treatments might enhance effectiveness by using both direct attack and immune system support. ^{1 2 6 7 8}

Who Is on the Research Team?

Miguel Villalona, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with advanced non-small cell lung cancer (NSCLC) that didn't respond to previous treatments targeting PD-1/PD-L1. Participants must have tried these therapies before and now need a new option.

Inclusion Criteria

I am 18 years old or older.

I am fully active or restricted in physically strenuous activity but can do light work.

ANC ≥ 1,500/mm^3

Exclusion Criteria

My brain cancer has not grown after treatment.

My cancer has EGFR mutations or ALK translocations and treatments have not worked.

I had a stem cell transplant using my own cells within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NK-102 as monotherapy or in combination with Atezolizumab to determine the maximum tolerated dose

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• NK-102

Trial Overview The study is testing NK-102, which are natural killer cells modified to fight cancer, either alone or combined with Atezolizumab, an existing immunotherapy drug. They're looking for the highest dose patients can take without serious side effects.

How Is the Trial Designed?

Group I: NK-102 +/- Atezolizumab Experimental Treatment 2 Interventions

Study participants will be assigned to a protocol-specified treatment dose level.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39758245/

Outcomes of Combined Atezolizumab Plus Chemotherapy ... Immune-related adverse events were observed in 27.7% of patients, with grade 3 or higher in 9.9% of patients, and grade 5 in 2.1% of patients.

2. cancerdiagnosisprognosis.org cancerdiagnosisprognosis.org/article/468/outcomes-of-combined-atezolizumab-plus-chemotherapy-in-non-small-cell-lung-cancer-patients-in-clinical-practice

Outcomes of Combined Atezolizumab Plus Chemotherapy ... Immune-related adverse events were observed in 27.7% of patients, with grade 3 or higher in 9.9% of patients, and grade 5 in 2.1% of patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0169500221001355

Real-world outcomes of immunotherapy–based regimens ... First-line (1L) immunotherapy (I-O) has improved outcomes in patients with advanced non-small cell lung cancer (NSCLC) in clinical trials and is now ...

4. lungcancerstoday.com lungcancerstoday.com/post/final-survival-results-from-phase-3-skyscraper-01-study-presented-at-aacr-2025

Phase 3 SKYSCRAPER-01 Study: Final PFS, OS Analyses ... Dr. Peters and colleagues explained that the combination of tiragolumab plus atezolizumab “has shown encouraging survival outcomes” in patients ...

5. jtd.amegroups.org jtd.amegroups.org/article/view/103249/html

Real-world efficacy of atezolizumab combined with etoposide ... Real-world efficacy of atezolizumab combined with etoposide and platinum chemotherapy in extensive-stage small cell lung cancer: a retrospective cohort study.

6. biospace.com biospace.com/press-releases/affimed-reports-positive-clinical-update-on-afm24-atezolizumab-combination-therapy-in-non-small-cell-lung-cancer-nsclc

Affimed Reports Positive Clinical Update on AFM24 ... In 33 heavily pretreated NSCLC EGFR wild-type (EGFRwt) patients the combination of AFM24 and atezolizumab shows an overall response rate ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT05109442

Study to Assess AFM24 in Combination With Atezolizumab ... Affimed to Host Investor Conference Call Highlighting Clinical Data from AFM24 in Combination with Atezolizumab in Non-Small Cell Lung Cancer.

8. withpower.com withpower.com/trial/phase-1-carcinoma-non-small-cell-lung-8-2025-4e3d3

NK-102 + Atezolizumab for Lung Cancer · Info for Participants This is a Phase 1 dose escalation clinical trial determining the maximum tolerated dose of NK-102 in subjects with advanced, metastatic, or recurrent ...