Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT05777603
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2023-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase I Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2025-10-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Background:
* Dysbiosis of the lung microbiome is commonly seen in patients with advanced non-small cell lung cancer (NSCLC). It is associated with increased bacterial burden and decreased bacterial diversity in tumors
* Preclinical studies using genetically engineered mouse (GEM) models show that dysbiosis of the lung microbiome promotes tumor growth in NSCLC
Objective:
\- To assess the safety of combined aerosolized antibiotics (aztreonam and vancomycin) with pembrolizumab IV, in participants with advanced NSCLC
Eligibility:
* Histological confirmation of NSCLC that is not amenable to surgery
* Disease has progressed after FDA-approved frontline therapy for NSCLC
* PD-L1Tumor Proportion Score (TPS) \>=1% detected at any time since diagnosis.
* Measurable and progressive disease
* Age \>=18 years
* ECOG performance status \<=2
* Participants must have adequate organ and bone marrow function
Design:
* This is a phase I, open-label, single-arm study evaluating the safety and feasibility of combined aerosolized antibiotics (aztreonam and vancomycin) and pembrolizumab in advanced NSCLC
* Participants will be given six cycles of treatments; each cycle is three weeks (21 days)
* Participants receive pembrolizumab 200mg IV on Day 1 of each cycle
* During cycles 1, 3 and 5, participants will self-administer aerosolized aztreonam 3 times a day and vancomycin twice a day from Day 2 through Day 21
* There are two dose levels of aerosolized antibiotics: participants start with Dose Level 1 (aztreonam 75mg three times a day and vancomycin 250mg twice a day)
* If participants cannot tolerate Dose Level 1, treatment will be de-escalated to Dose Level
* 1 (aztreonam 75mg once a day and vancomycin 250mg once a day)
* Participants will be enrolled based on "3+3" scheme to test the primary endpoints of safety and feasibility
* Up to 18 evaluable participants will be enrolled
* Dysbiosis of the lung microbiome is commonly seen in patients with advanced non-small cell lung cancer (NSCLC). It is associated with increased bacterial burden and decreased bacterial diversity in tumors
* Preclinical studies using genetically engineered mouse (GEM) models show that dysbiosis of the lung microbiome promotes tumor growth in NSCLC
Objective:
\- To assess the safety of combined aerosolized antibiotics (aztreonam and vancomycin) with pembrolizumab IV, in participants with advanced NSCLC
Eligibility:
* Histological confirmation of NSCLC that is not amenable to surgery
* Disease has progressed after FDA-approved frontline therapy for NSCLC
* PD-L1Tumor Proportion Score (TPS) \>=1% detected at any time since diagnosis.
* Measurable and progressive disease
* Age \>=18 years
* ECOG performance status \<=2
* Participants must have adequate organ and bone marrow function
Design:
* This is a phase I, open-label, single-arm study evaluating the safety and feasibility of combined aerosolized antibiotics (aztreonam and vancomycin) and pembrolizumab in advanced NSCLC
* Participants will be given six cycles of treatments; each cycle is three weeks (21 days)
* Participants receive pembrolizumab 200mg IV on Day 1 of each cycle
* During cycles 1, 3 and 5, participants will self-administer aerosolized aztreonam 3 times a day and vancomycin twice a day from Day 2 through Day 21
* There are two dose levels of aerosolized antibiotics: participants start with Dose Level 1 (aztreonam 75mg three times a day and vancomycin 250mg twice a day)
* If participants cannot tolerate Dose Level 1, treatment will be de-escalated to Dose Level
* 1 (aztreonam 75mg once a day and vancomycin 250mg once a day)
* Participants will be enrolled based on "3+3" scheme to test the primary endpoints of safety and feasibility
* Up to 18 evaluable participants will be enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 001516-C | None | None | View |