Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249854
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-01-09
Brief Title:
Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Korea Institute of Oriental Medicine
Organization:
Korea Institute of Oriental Medicine
Study Overview
Official Title:
A Multicenter Open Label Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer
Status:
RECRUITING
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:
This is a multicenter open-label randomized controlled clinical trial designed to evaluate the efficacy and safety of combination therapy with Bojungikki-tangBJIKT and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic tumor aberrations
Based on prior pre-clinical studies the combination of Bojungikki-tang and immune checkpoint inhibitors ICIs can be expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment
Therefore this clinical trial aims to assess the efficacy and safety of the combined therapy with BJIKT and pembrolizumab and establish clinical evidence for an integrative cancer treatment strategy by examining the survival rate and immune status following combined ICI and BJIKT treatment
Based on prior pre-clinical studies the combination of Bojungikki-tang and immune checkpoint inhibitors ICIs can be expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment
Therefore this clinical trial aims to assess the efficacy and safety of the combined therapy with BJIKT and pembrolizumab and establish clinical evidence for an integrative cancer treatment strategy by examining the survival rate and immune status following combined ICI and BJIKT treatment
Detailed Description:
This is a multicenter open-label randomized controlled clinical trial to evaluate the efficacy and safety of combination therapy with Bojungikki-tangBJIKT and pembrolizumab monotherapy in patients with advanced non-small cell lung cancer whose tumors express PD-L1 positive with no EGFR or ALK genomic tumor aberrations A total of 70 patients aged 19 or older will be enrolled in the study and progression-free survival PFS will be assessed as the primary endpoint
In a pre-clinical study the combination of immune checkpoint inhibitorsICIs and Bojungikki-tang extended the survival of mice compared to the administration of ICIs or BJIKT alone and reduced tumor volume and weight In addition it was confirmed that various immune-related factors in the tumor microenvironment were controlled to improve the immunosuppressed microenvironment and to strengthen the tumor immune response by increasing major immune cytokines in the blood Furthermore the combination of ICIs and BJIKT did not cause pharmacodynamic and pharmacokinetic drug interactions and significant side effects of Bojungikki-tang were not observed in most clinical reports on long-term administration of Bojungikki-tang Based on the results the combination of BJIKT and ICIs is expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment
In order to evaluate efficacy variables including PFS disease control rate DCR overall survival OS and quality of life will be used The incidence rate of adverse events AEs and AEs with CTCAE grade 3 or higher will be assessed for safety Most variables will be followed up during and after 45-week treatment and the safety of interventions will be monitored consistently Immune profiling and multi-omics analyses including transcriptomic proteomic and metabolomic evaluations of PBMCs will be conducted for exploratory purposes In addition pattern identification a traditional diagnostic method in East Asian medicine will be utilized as an exploratory variable A validated questionnaire assessing Cold-Heat patterns tongue diagnosis data and pulse diagnosis data will be used to investigate their correlation with clinical and laboratory data
In a pre-clinical study the combination of immune checkpoint inhibitorsICIs and Bojungikki-tang extended the survival of mice compared to the administration of ICIs or BJIKT alone and reduced tumor volume and weight In addition it was confirmed that various immune-related factors in the tumor microenvironment were controlled to improve the immunosuppressed microenvironment and to strengthen the tumor immune response by increasing major immune cytokines in the blood Furthermore the combination of ICIs and BJIKT did not cause pharmacodynamic and pharmacokinetic drug interactions and significant side effects of Bojungikki-tang were not observed in most clinical reports on long-term administration of Bojungikki-tang Based on the results the combination of BJIKT and ICIs is expected to improve survival and enhance the therapeutic efficacy of ICIs by modulating the systemic tumor-immune environment
In order to evaluate efficacy variables including PFS disease control rate DCR overall survival OS and quality of life will be used The incidence rate of adverse events AEs and AEs with CTCAE grade 3 or higher will be assessed for safety Most variables will be followed up during and after 45-week treatment and the safety of interventions will be monitored consistently Immune profiling and multi-omics analyses including transcriptomic proteomic and metabolomic evaluations of PBMCs will be conducted for exploratory purposes In addition pattern identification a traditional diagnostic method in East Asian medicine will be utilized as an exploratory variable A validated questionnaire assessing Cold-Heat patterns tongue diagnosis data and pulse diagnosis data will be used to investigate their correlation with clinical and laboratory data
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