Bethesda, MDNCT05777603Now EnrollingIRB Ready

Advanced Non Small Cell Lung Cancer Clinical Trial in Bethesda, MD

Access cutting-edge advanced non small cell lung cancer treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Cancer Institute (NCI)

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Expert Care in Bethesda

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related advanced non small cell lung cancer treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Advanced Non Small Cell Lung Cancer Study in Bethesda

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.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Histologically or cytologically non-small cell lung cancer confirmed by outside pathology report or via the Laboratory of Pathology, NCI.
Have measurable disease, per RECIST 1.1, that is not amenable to surgery.
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: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list- cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.
Patient s disease has progressed after FDA-approved frontline therapy for NSCLC.
Age \>=18 years.
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 \>=60 mL/min/1.73 m\^2 (calculated based on CKD-EPI formula or directly measured) for participants with creatinine levels above institutional normal.
Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
Participants with new or progressive brain metastases (active brain metastases) are eligible if immediate CNS specific treatment is not required per standard of care and is unlikely to be required during the first cycle of therapy.
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.
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
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.
Individuals of child-bearing potential (IOCBP) 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.
Breastfeeding participants must be willing to discontinue breastfeeding for the duration of study treatment.
Ability of participant to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Participants who are receiving any other investigational agents.
Participants with ongoing Epstein-Barr virus or cytomegalovirus infection
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, aztreonam, vancomycin and albuterol.
Pregnancy (confirmed with beta-HCG serum or urine pregnancy test performed in individuals of childbearing potential at screening).
Pulmonary function FEV1 (Forced Expiratory Volume in the first second) \<25% will be excluded based on the requirement of receiving aerosolized aztreonam.
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.
Uncontrolled intercurrent illness that would limit compliance with study requirements.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT05777603) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Non Small Cell Lung Cancer Treatment Options in Bethesda, MD

If you're searching for advanced non small cell lung cancer treatment options in Bethesda, MD, this clinical trial (NCT05777603) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced non small cell lung cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced non small cell lung cancer clinical trials near you to find additional studies recruiting in your area.

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