Actively Recruiting
Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-04-09
23
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Non-small cell lung cancer (NSCLC) can be hard to treat and is often fatal. People with NSCLC commonly have changes in the bacteria that populate their lungs. These bacterial changes may aid tumor growth. Researchers want to find out if treating the bacteria, too, can help cancer treatment work better. Objective: To test 2 inhaled antibiotics (aztreonam and vancomycin), combined with a standard cancer treatment, in people with NSCLC. Eligibility: People aged 18 years and older with NSCLC that has returned or progressed after treatment and cannot be treated with surgery. Design: Participants will be screened. They will have a physical exam with blood tests. They may blow into a machine to test how well their lungs work. They will have imaging scans. They may need to have a small piece of tissue cut from their tumor (biopsy). Participants will be treated in six 21-day cycles. They will visit the clinic to receive a drug for cancer treatment on the first day of each cycle. This drug will be administered through a tube attached to a needle inserted into a vein in the arm. The 2 antibiotic drugs will be in the form of a fine mist that can be inhaled. Participants use a device to take these drugs at home. They will inhale aztreonam up to 3 times a day and vancomycin 1 or 2 times a day. They will take these drugs during only 3 of the treatment cycles. Biopsies and other tests will be repeated halfway through and after the study treatment. Follow-up visits will continue for 1 year after study treatment.
CONDITIONS
Official Title
Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-small cell lung cancer not suitable for surgery
- Measurable disease per RECIST 1.1
- PD-L1 Tumor Proportion Score (TPS) 1% or higher at any time since diagnosis
- Disease progressed after FDA-approved frontline therapy for NSCLC
- Age 18 years or older
- ECOG performance status 2 or less
- Adequate organ and marrow function, including leukocytes >=3,000/mcL, absolute neutrophil count >=1,500/mcL, platelets >=100,000/mcL, normal bilirubin, AST/ALT <=2.5 times normal, and creatinine clearance >=60 mL/min/1.73 m2
- Treated brain metastases allowed if stable on follow-up imaging
- Active brain metastases allowed if immediate treatment not required
- HIV-infected participants with undetectable viral load on therapy
- Chronic hepatitis B infection with undetectable viral load on therapy
- Hepatitis C infection treated and cured or undetectable viral load if on treatment
- Individuals of child-bearing potential must use effective contraception during and for 4 months after therapy
- Breastfeeding participants must agree to stop breastfeeding during treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving any other investigational agents
- Ongoing Epstein-Barr virus or cytomegalovirus infection
- History of allergic reactions to pembrolizumab, aztreonam, vancomycin, or albuterol
- Pregnancy
- Pulmonary function FEV1 less than 25%
- History of severe immune-related adverse events including neurological, cardiac, grade 3 or 4 irAEs (except controlled endocrine irAEs), or pneumonitis
- Uncontrolled illnesses that limit study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Shannon G Swift, R.N.
CONTACT
C
Chen Zhao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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