Status and phase
Conditions
Treatments
About
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.
Full description
Background:
Primary Objectives:
Eligibility:
Design:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
prior to enrollment.
dose of the drug.
-Participant must be able to understand and willing to sign an informed consent.
EXCLUSION CRITERIA:
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
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Central trial contact
David S Schrump, M.D.; Deneise Francis, R.N.
Data sourced from clinicaltrials.gov
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