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Could clearing lung bacteria boost cancer treatment?

NCT ID NCT05777603

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-phase trial tests whether adding two inhaled antibiotics (aztreonam and vancomycin) to the standard cancer drug pembrolizumab can help treat advanced non-small cell lung cancer (NSCLC). The idea is that harmful bacteria in the lungs may help tumors grow, so clearing them might make the cancer treatment work better. About 23 adults with NSCLC that has returned or progressed will take the antibiotics at home for three 21-day cycles while receiving pembrolizumab at the clinic.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aerosolized aztreonam, aerosolized vancomycin, and pembrolizumab
What this could lead to
If it works, this could point toward a way to make standard cancer treatment more effective by also treating lung bacteria.
What could go wrong
This is a very early Phase 1 trial with only 23 people, so it is primarily testing safety and dosing. It may not improve outcomes, and the antibiotics can cause side effects like cough or allergic reactions.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 23 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 120 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

-INCLUSION CRITERIA: 1. Histologically or cytologically non-small cell lung cancer confirmed by outside pathology report or via the Laboratory of Pathology, NCI. 2. Have measurable disease, per RECIST 1.1, that is not amenable to surgery. 3. PD-L1 Tumor Proportion Score (TPS) \>=1% detected at any time since diagnosis, based on a pathology report from an outside hospital or Laboratory of Pathology, NCI. PD- L1 expression testing must be conducted using one of the FDA approved diagnostic devices listed here: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list- cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools. 4. Patient s disease has progressed after FDA-approved frontline therapy for NSCLC. 5. Age \>=18 years. 6. ECOG performance status \<=2. 7. Must have adequate organ and marrow function as defined below: * 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. EXCLUSION CRITERIA: 1. Participants who are receiving any other investigational agents. 2. Participants with ongoing Epstein-Barr virus or cytomegalovirus infection 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, aztreonam, vancomycin and albuterol. 4. Pregnancy (confirmed with beta-HCG serum or urine pregnancy test performed in individuals of childbearing potential at screening). 5. Pulmonary function FEV1 (Forced Expiratory Volume in the first second) \<25% will be excluded based on the requirement of receiving aerosolized aztreonam. 6. History of severe immune-related adverse events (irAEs), defined as any grade neurological or cardiac irAEs, any grade 3 or 4 irAE (except fully controlled endocrine irAEs with appropriate hormone supplementation), and any grade pneumonitis. 7. Uncontrolled intercurrent illness 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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