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NCT05777603 · ClinicalTrials.gov registry record · Phase 1
Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
A Phase 1 study of Advanced Non-Small-Cell Lung Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT05777603: Recruiting Phase 1 study of Advanced Non-Small-Cell Lung Cancer, sponsored by National Cancer Institute (NCI).
NCT05777603 is a Phase 1 study of Advanced Non-Small-Cell Lung Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 382-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05777603, a Phase 1 study of Advanced Non-Small-Cell Lung Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Safety will be evaluated by reported grades of toxicities, including DLTs at each dose levels.
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG aerosolized aztreonam
- DRUG aerosolized vancomycin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 1 |
What NCT05777603 shows while recruiting
NCT05777603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 382-participant average among 22 other Advanced Non-Small-Cell Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Advanced Non-Small-Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which pembrolizumab is the first listed.
NCT05777603 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05777603 about?
NCT05777603 is a clinical study titled "Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer". 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 treatm...
What is the current status of trial NCT05777603?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2024-04-18. Estimated completion is 2028-06-01.
What conditions does trial NCT05777603 study?
This clinical trial studies the following conditions: Advanced Non-Small-Cell Lung Cancer.
What interventions are being tested in trial NCT05777603?
The interventions under investigation include: pembrolizumab (DRUG), aerosolized aztreonam (DRUG), aerosolized vancomycin (DRUG).
Who is sponsoring clinical trial NCT05777603?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05777603 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05777603's enrollment target sits among peer trials
23 21st of 22 higher than 2 of 22 other Advanced Non-Small-Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Non-Small-Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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