RecruitingPhase 1NCT05777603

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

Phase I Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-Small Cell Lung Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

23 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed. It combines an inhaled antibiotic (aerosolized aztreonam) with pembrolizumab, a standard immunotherapy drug. The idea is that changing the bacteria in the lungs (the lung microbiome) might help the immune system fight the cancer more effectively. **You may be eligible if:** - You have been diagnosed with non-small cell lung cancer confirmed by biopsy - Your cancer has a certain protein marker (PD-L1 ≥1%) and is not eligible for surgery - Your cancer has worsened after receiving standard first-line treatment - You are 18 or older with good overall health (ECOG status 0–2) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if:** - You are currently receiving other experimental treatments - You have an active Epstein-Barr or cytomegalovirus infection - You are allergic to pembrolizumab, aztreonam, vancomycin, or albuterol - You are pregnant or breastfeeding - Your lung function is severely reduced (FEV1 below 25%) - You had serious immune-related side effects from prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGaerosolized aztreonam

antibiotic with gram-negative bacteria coverage

DRUGaerosolized vancomycin

antibiotic with gram-positive bacteria coverage

DRUGpembrolizumab

standard of care therapy/monoclonal antibody for patients with advanced NSCLC


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT05777603


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