Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

Paused · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Carcinomas

In brief

Background: Surgery is the primary treatment for non-small cell lung cancer (NSCLC) that is diagnosed in its earlier stages. But the tumors often return. Radiation and chemotherapy can improve survival in some people who have had surgery for NSCLC, but these treatments also cause serious side effects. A new approach, called immunotherapy, may be a better way to stop NSCLC tumors from coming back. Objective: To test a new treatment (H1299 lung cancer cell vaccine combined with the drug N-803) in people who received surgery for NSCLC. Eligibility: Adults aged 18 years or older with no sign of disease after surgery for NSCLC. Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans. Study treatment will be given in 28-day cycles. Participants will visit the clinic on the first day of each cycle. They will receive 2 treatments at each visit: The study vaccine is given as 2-4 small shots under the skin of the thigh or arm. N-803 is given as a shot under the skin of the abdomen. Treatment will continue for 6 cycles. Blood tests and imaging scans will be repeated throughout the study. Participants will have a blood test 1 month after receiving the 6th vaccine. Some participants may then resume taking N-803; they may also receive 2 more vaccinations at 3 and 6 months after their previous treatment. Follow-up visits will continue for up to 5 years.

Key facts

Study ID

NCT05642195

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2026-08-13

Expected to finish

2035-12-30

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participants receiving other investigational agents.
• Participants on any active treatment for their cancer upon study entry.
• Participant who is initially rendered NED or have MRD following standard therapy but exhibit disease progression prior to initiation of vaccination.
• Participant requiring chronic systemic treatment with steroids above physiologic doses.
• Participant receiving warfarin anticoagulation, who cannot be transitioned to other agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held for up to 24 hours.
• Participant with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated CHF (> NYHA Class II), or myocardial infarction within 6 months prior to initiation of study therapy.
• Participant with any of the following pulmonary function abnormalities: FEV, < 35% predicted; DLCO < 35% predicted (post-bronchodilator); oxygen saturation less than 92% on room air based on assessment at NIH or outside medical facility no more than 4 weeks prior to protocol enrollment.
• Active COVID infection
• Participant pregnancy
• Uncontrolled intercurrent illness occurring within 3 months prior to initiation of study therapy /social situations (as assessed by social services) that would limit compliance with study requirements.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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