Experimental vaccine aims to stop lung cancer from coming back
NCT ID NCT05642195
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 59 times
Summary
This trial tests a vaccine made from lung cancer cells, combined with an immune-boosting drug (N-803), in people who have had surgery for non-small cell lung cancer (NSCLC) that is PD-L1 negative. The goal is to see if the vaccine can train the immune system to destroy any remaining cancer cells and prevent the cancer from returning. Up to 30 adults with no signs of active disease after surgery will receive the vaccine and N-803 over several months, with close monitoring for safety and immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- H1299 lung cancer cell lysate vaccine with Montanide ISA-51 VG adjuvant, with or without N-803 (IL-15 superagonist)
- What this could lead to
- If successful, this could offer a new immunotherapy option to reduce the risk of lung cancer returning after surgery for patients with PD-L1 negative tumors.
- What could go wrong
- This is an early phase 1/2 trial with only 30 participants, currently suspended. The vaccine is experimental, and it is unknown if it will effectively prevent recurrence or cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2035
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Participant with histologically or cytologically proven Stage IB-IIIA (T2a-T4/N0, T1- T3N1, T1-T2/N2) NSCLC per 8th edition TNM Staging System with no clinical evidence of active disease (NED) or minimal residual disease (MRD) not readily accessible by non-invasive biopsy or resection/radiation following standard therapy. Initial diagnosis must be confirmed by the NIH Laboratory of Pathology. * History of PD-L1 expression in cancer cells \< 1% as determined by IHC analysis. * Participant must be enrolled within 12 weeks following completion of prior SOC therapy. * Participant must have an ECOG performance status of 0-2. * Participant must be \>=18 years of age. * Participant must be willing to co-enroll on protocol 06C0014 (Prospective Analysis of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies) allowing for the collection of blood for correlative experiments pertaining to this protocol and related translational research efforts in the Thoracic Surgery Branch. * Participant must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters (all eligibility assessment/enrollment bloodwork must be done at NIH no more than 2 weeks prior to enrollment): * Absolute neutrophil count greater than 1500/mm3 * Absolute lymphocyte count greater than 800/mm3 * Platelet count greater than 75,000/mm3 * Hemoglobin greater than 8 g/dL (participant may receive transfusions to meet this parameter) * INR\< 1.5xULN * Total bilirubin \< 1.5 x upper limits of normal (except those with Gilberts disease) * Serum creatinine less than or equal to 1.6 mg/mL or the eGFR must be greater than 60 mL/min/1.73m2 * Seronegative for HIV antibody by bloodwork performed at NIH no more than 4 weeks prior to enrollment. * Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RTPCR and be HCV RNA negative by bloodwork performed at NIH no more than 4 weeks prior to enrollment. * Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding while receiving investigational treatment and for 120 days after the last dose of vaccine or N-803. * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) within 28 days prior initiation of study therapy, for the duration of study participation and up to 120 days after the last dose of the drug. -Participant must be able to understand and willing to sign an informed consent. EXCLUSION CRITERIA: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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