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

NCT05777603 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Advanced Non Small Cell Lung Cancer

Interventions

DRUG

aerosolized aztreonam

antibiotic with gram-negative bacteria coverage

DRUG

aerosolized vancomycin

antibiotic with gram-positive bacteria coverage

DRUG

pembrolizumab

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-18
Primary Completion
2027-06-01
Completion
2028-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05777603 on ClinicalTrials.gov