Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924374
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2021-05-07
Brief Title:
Microbiota Transplant in Advanced Lung Cancer Treated With Immunotherapy
Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Organization:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Overview
Official Title:
Microbiota Transplant in Advanced Lung Cancer Treated With Immunotherapy
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The gut microbiota can modulate the effectiveness of cancer therapies especially immunotherapy Manipulating the microbial populations in patients with advanced lung cancer through fecal microbiota transplantation from healthy individuals or from long-term survivors to advanced lung cancer will enhance the efficacy of immunotherapy
Detailed Description:
Lung cancer is a leading cause of mortality worldwide and its treatment and prognosis are being revolutionized by immunotherapy The gut microbiome has been shown able to modulate the antitumor efficacy of immunotherapeutic agents in pre-clinical models demonstrating that patients can be stratified into responders and nonresponders to immunotherapy on the basis of their microbiota composition Fecal microbiota transplants have demonstrated to improve the efficacy of immunotherapy in animal models In this study investigators will include 20 stage IIIV non-small cell lung cancer naïve for PDPD L-1 inhibitors that require treatment in monotherapy or combined with chemotherapy as consolidation strategy after concurrent chemotherapy and radiotherapy stage III upfront treatment stage IV patients with PDL1 status 50 or as second line strategy for those patients with advanced disease who progressed to chemotherapy alone The participants will be randomized to receive either fecal microbiota capsules from 3 donors selected based on the fecal abundance of bacterial taxa shown to correlate with a greater response to immunotherapy or not in combination with the PDLPDL1 agent The primary outcome will be safety The secondary outcomes will be treatment response iRECIST criteria Investigators will also examine engraftment of donors microbiota on host microbiota using Illumina DNA shotgun sequencing changes in the bacterial metabolism using metaproteomics and in the plasma metabolite fingerprint by untargeted mass spectrometry in bacterial and plasma samples and changes in peripheral immune cells subpopulations and antitumoral immunity MORELIA could improve the prognosis of a lung cancer in a subset of patients with limited therapeutic options and inform on how to exploit host-microbiota interactions with tailored fecal microbiota transplantation to boost the clinical response to immunotherapy in advanced cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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