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SUSPENDED
NCT05642195
PHASE1/PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-19

Completion Date

2035-12-30

Last Updated

2026-04-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

Montanide (Registered Trademark) ISA-51 VG Adjuvant

H1299 cell lysate with Montanide (Registered Trademark) ISA-51 VG adjuvant vaccine via subcutaneous injections once every cycle (1 cycle=28 days) for 6 cycles (i.e., 6 vaccinations). Dose Level 1 (DL1) starting dose is 20 mcg lysate protein in 2-2.5 mL Montanide (Registered) ISA-51 VG adjuvant; lysate concentration will be 8-10 mcg/mL. Additional 2 vaccine injections for subjects with immunologic response and NED.

BIOLOGICAL

H1299 Cell Lysates

H1299 cell lysate with Montanide (Registered) ISA-51 VG adjuvant vaccine via subcutaneous injections once every cycle (1 cycle=28 days) for 6 cycles (i.e., 6 vaccinations). Dose Level 1 (DL1) starting dose is 20 mcg lysate protein in 2-2.5 mL Montanide (Registered Trademark) ISA-51 VG adjuvant; lysate concentration will be 8-10 mcg/mL. Additional 2 vaccine injections for subjects with immunologic response and NED.

DRUG

N-803

N-803 via subcutaneous injection in the abdomen at dose of 15 ug/kg every 4 weeks, on Day 1 of each cycle. N-803 dosing will be calculated using a weight obtained within 5 days prior to the first dose. Dose re-calculated at the beginning of each subsequent cycle in the event of a 10% or greater weight change.

DEVICE

Ventana PD-L1 (SP263 or SP142) assay

FDA-approved assays used off-label for study as treatment determining in-vitro diagnostic devices to assess subject PD-L1 quantitation. Testing will be performed on provided archival samples or on fresh sample that is collected at screening for confirmation of diagnosis; no additional sample collection for purposes of PD-L1 testing.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States