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Aerosolized Antibiotics and Pembrolizumab for Advanced Non-small Cell Lung Cancer

This study is looking at a new way to treat advanced non-small cell lung cancer (NSCLC) by combining standard cancer treatment with inhaled antibiotics. Researchers believe that changes in the bacteria in the lungs of people with NSCLC might help tumors grow. This study will test if giving two inhaled antibiotics, aztreonam and vancomycin, along with pembrolizumab (a common cancer treatment), can be safe and effective. You might be able to join if you are 18 or older, have advanced NSCLC that has progressed after prior treatment and cannot be removed by surgery, and your tumor shows a PD-L1 score of 1% or higher. The main goal is to see if this combination causes any serious side effects. The study plans to enroll 23 participants, but its current status is unclear.

Study design
This is a Phase 1, open-label, single-arm study, meaning all participants will receive the same treatment, and both you and the study team will know what treatments you are getting. It aims to enroll 23 participants.
What's involved
You will undergo screening, which includes a physical exam, blood tests, lung function tests, and imaging scans. If eligible, you will receive six cycles of treatment, with each cycle lasting three weeks. You will receive pembrolizumab intravenously (into a vein) on Day 1 of each cycle, and you will self-administer aerosolized aztreonam three times a day and vancomycin twice a day during cycles 1, 3, and 5.
Compensation
Not stated in the trial record.
Follow-up
The study will track dose-limiting toxicities (side effects) from the start of therapy through 1 year after your last study drug dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05777603

Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~23 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:aerosolized aztreonamaerosolized vancomycinpembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLTs) - type and grade
Measured over Start of therapy through 1 year after last study drug dose

Conditions

Advanced Non Small Cell Lung Cancer

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Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Chen Zhao, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Shannon G Swift, R.N.
[email protected]
(240) 858-3157
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Leukocytes \>=3,000/mcL
absolute neutrophil count \>=1,500/mcL
platelets \>=100,000/mcL
total bilirubin\<TAB\>within normal institutional limits
AST/ALT \<=2.5 X institutional upper limit of normal
creatinine clearance \>=60 mL/min/1.73 m\^2 (calculated based on CKD-EPI formula or directly measured) for participants with creatinine levels above institutional normal. 8. Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 9. Participants with new or progressive brain metastases (active brain metastases) are eligible if immediate CNS specific treatment is not required per standard of care and is unlikely to be required during the first cycle of therapy. 10. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within the 6 months before study treatment initiation are eligible for this trial. 11. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 12. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 13. Individuals of child-bearing potential (IOCBP) must agree to use effective contraception (e.g., hormonal intrauterine device \[IUD\], tubal ligation, partner has had prior vasectomy) beginning at study entry until 4 months after the completion of therapy. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the participant, is also acceptable. 14. Breastfeeding participants must be willing to discontinue breastfeeding for the duration of study treatment. 15. Ability of participant to understand and the willingness to sign a written informed consent document.

What this trial measures

  • Dose limiting toxicities (DLTs) - type and gradeStart of therapy through 1 year after last study drug dose

    Safety will be evaluated by reported grades of toxicities, including DLTs at each dose levels.