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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;
Adults who are or may become unable to consent


Immune Checkpoint Inhibitor;
lung microbiota;
anti-PD1 antibody;
inhaled antibiotic

Recruitment Keyword(s)



advanced non small cell lung cancer

Investigational Drug(s)


Investigational Device(s)



Drug: aerosolized aztreonam
Drug: aerosolized vancomycin
Drug: pembrolizumab

Supporting Site

National Cancer Institute


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.


To test 2 inhaled antibiotics (aztreonam and vancomycin), combined with a standard cancer treatment, in people with NSCLC.


People aged 18 years and older with NSCLC that has returned or progressed after treatment and cannot be treated with surgery.


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.

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1. Histologically or cytologically non-small cell lung cancer confirmed by outside pathology report or via the Laboratory of Pathology, NCI.

2. Have measurable disease, per RECIST 1.1, that is not amenable to surgery.

3. PD-L1 Tumor Proportion Score (TPS) >=1% detected at any time since diagnosis, based on a pathology report from an outside hospital or Laboratory of Pathology, NCI. PD- L1 expression testing must be conducted using one of the FDA approved diagnostic devices listed here: cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.

4. Received at least one previous line of standard frontline therapy that must include a PD-1/PD-L1-targeting ICI.

5. Age >=18 years.

6. ECOG performance status <=2.

Must have adequate organ and marrow function as defined below:

Leukocytes >=3,000/mcL

absolute neutrophil count >=1,500/mcL

platelets >=100,000/mcL

total bilirubin<TAB>within normal institutional limits

AST/ALT <=2.5 X institutional upper limit of normal

creatinine clearance<TAB>>=60 mL/min/1.73 m^2 (calculated based on CKD-EPI formula or directly measured) for participants with creatinine levels above institutional normal.

7. Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.

8. Participants with new or progressive brain metastases (active brain metastases) are eligible if immediate CNS specifictreatment is not required per standard of care and is unlikely to be required during the first cycle of therapy.

9. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within the 6 months before study treatment initiation are eligible for this trial.

10. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

11. 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.

12. Women of child-bearing potential (WOCBP) must agree to use effective contraception (e.g., hormonal intrauterine device [IUD], tubal ligation, partner has had prior vasectomy) beginning at study entry until 4 months after the completion of therapy. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the participant is also acceptable.

13. Breastfeeding participants must be willing to discontinue breastfeeding for the duration of study treatment.

14. Ability of participant to understand and the willingness to sign a written informed consent document.


1. Participants who are receiving any other investigational agents.

2. Participants with ongoing Epstein-Barr virus or cytomegalovirus infection

3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, aztreonam, vancomycin and albuterol.

4. Pregnancy (confirmed with beta-HCG serum or urine pregnancy test performed in females of childbearing potential at screening).

5. Pulmonary function FEV1 (Forced Expiratory Volume in the first second) <25% will be excluded based on the requirement of receiving aerosolized aztreonam.

6. Participants with targetable EGFR, ALK, ROS1, BRAF V600E, NTRK1/2/3, METex14 skipping, RET, and HER2 genomic tumor aberrations. Genomic testing must be based on a pathology report from an outside hospital or Laboratory of Pathology, NCI and must be conducted using TSO500 or one of the FDA approved diagnostic devices listed here: approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.

7. Participants with KrasG12C mutation not previously treated with sotorasib or other approved KrasG12C small molecule inhibitor.

8. History of severe immune-related adverse events (irAEs), defined as any grade neurological or cardiac irAEs, any grade 3 or 4 irAE (except fully controlled endocrine irAEs with appropriate hormone supplementation), and any grade pneumonitis.

9. Uncontrolled intercurrent illness that would limit compliance with study requirements.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Chen Zhao, M.D.
National Cancer Institute (NCI)
NIHBC 04 BG RM 109
(301) 646-8331

Shannon G. Swift, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D48
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3157

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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