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Monoclonal Antibodies
Aerosolized Antibiotics + Pembrolizumab for Lung Cancer
Phase 1
Recruiting
Led By Chen Zhao, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Histologically or cytologically non-small cell lung cancer confirmed by outside pathology report or via the Laboratory of Pathology, NCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between start of therapy through 1 year after last study drug dose.
Awards & highlights
Study Summary
This trial tests if antibiotics, taken with cancer treatment, can help treat people w/ NSCLC. Participants take antibiotics at home & get cancer drug at clinic. Tests/scans done to monitor progress. Follow-up for 1 year after study.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests two inhaled antibiotics (aztreonam and vancomycin), combined with pembrolizumab (a standard cancer drug), for NSCLC. Participants will undergo six cycles of treatment including clinic visits for pembrolizumab infusions and at-home inhalation of the antibiotics during three cycles.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation by pembrolizumab such as inflammation in various organs, fatigue, skin issues, digestive problems; plus potential lung irritation or infection from inhaling the antibiotics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My lung cancer diagnosis has been confirmed by a lab report.
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I am breastfeeding but willing to stop during the study.
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My hepatitis B virus load is undetectable with treatment.
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My cancer has a PD-L1 score of 1% or higher.
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My blood tests show my organs are functioning well.
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I have been treated with a PD-1/PD-L1 inhibitor before.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer can be measured but cannot be removed with surgery.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of therapy through 1 year after last study drug dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of therapy through 1 year after last study drug dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Dose limiting toxicities (DLTs) - type and grade
Fraction of participants who received adequate doses of all agents at each dose level
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment3 Interventions
Pembrolizumab + de-escalating doses of aztreonam and vancomycin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,885 Total Patients Enrolled
Chen Zhao, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
22 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am breastfeeding but willing to stop during the study.My lung function is better than 25% of the expected value.I am HIV-positive, on effective treatment, and my viral load has been undetectable for the last 6 months.My hepatitis B virus load is undetectable with treatment.You currently have an active Epstein-Barr virus or cytomegalovirus infection.My cancer has a PD-L1 score of 1% or higher.I have had severe side effects from immune therapy affecting my nerves, heart, lungs, or were very serious.I can take care of myself but might not be able to do heavy physical work.If you are a woman who could become pregnant, you must not be pregnant when you are screened for the trial.My brain cancer has not worsened after treatment.My lung cancer diagnosis has been confirmed by a lab report.I have been treated with a PD-1/PD-L1 inhibitor before.My blood tests show my organs are functioning well.My cancer has specific genetic changes and was tested with an FDA-approved method.I am allergic to medications similar to pembrolizumab, aztreonam, vancomycin, or albuterol.My cancer can be measured but cannot be removed with surgery.My cancer has a KrasG12C mutation and I haven't been treated with sotorasib or similar drugs.I am 18 years old or older.I have brain metastases but don't need immediate treatment for them.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for me to be a part of this medical experiment?
"To participate in this trial, patients must have non-small cell lung cancer and be between 10 to 120 years old. A total of 20 individuals will eventually join the cohort."
Answered by AI
Is Arm 1 compliant with FDA regulations?
"Arm 1 of the trial has been afforded a safety rating of one due to there being limited information regarding its efficacy and level of risk."
Answered by AI
Does this experimental protocol welcome elderly participants?
"To join this clinical study, patients must be in the 10 to 120 age range. However, those under 18 have 40 trials available and 1901 are open for seniors aged 65 or higher."
Answered by AI
Is there an opportunity to enlist in this research endeavor?
"The clinical trial's records hosted on the website indicate that this study is no longer actively recruiting patients. It was first posted on March 28th 2023, and its last update happened 5 days prior to that date. However, there are currently about 1910 other trials still enrolling participants for their research."
Answered by AI
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