Aerosolized Antibiotics + Pembrolizumab for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is the combination of aerosolized antibiotics and pembrolizumab safe for humans?
Pembrolizumab (Keytruda) has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, cough, nausea, and more serious immune-related issues such as pneumonitis (lung inflammation). While specific safety data for the combination with aerosolized antibiotics is not available, pembrolizumab's safety profile is well-documented in other conditions.12345
What makes the drug pembrolizumab unique for lung cancer treatment?
Pembrolizumab is unique because it is an immune checkpoint inhibitor that targets the PD-1 pathway, helping the immune system recognize and attack cancer cells, and it is used in combination with aerosolized antibiotics for lung cancer, which is a novel approach compared to traditional chemotherapy.13467
What data supports the effectiveness of the drug pembrolizumab for lung cancer?
Who Is on the Research Team?
Chen Zhao, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults over 18 with advanced non-small cell lung cancer (NSCLC) that's worsened after treatment and can't be surgically removed. They must have had prior therapy targeting PD-1/PD-L1, measurable disease, proper organ function, no severe allergies to trial drugs or similar compounds, and agree to use contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab IV on Day 1 of each 21-day cycle, and self-administer aerosolized antibiotics during cycles 1, 3, and 5
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aztreonam
- Pembrolizumab
- Vancomycin
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor