Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05777603
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-03-18
Brief Title:
Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-10-09
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
Received at least one previous line of standard frontline therapy that must include a PD-1PD-L1-targeting ICI
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 33 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
Received at least one previous line of standard frontline therapy that must include a PD-1PD-L1-targeting ICI
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 33 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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001516-C | None | None | None |