Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554613
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Two-arm Multicenter Phase II Randomized Controlled Trial Assessing the Impact of Olanzapine on the Efficacy of First-line Immunotherapy in Patients With Advanced EGFR Mutation-negative Non-small Cell Lung Cancer NSCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical Trial
The objective of this clinical trial is to determine whether antidepressant medications such as olanzapine in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone The main questions it aims to answer are
Is the combination therapy of antidepressant medication with immune checkpoint inhibitors more efficacious than the therapy with immune checkpoint inhibitors alone What medical issues might participants encounter when treated with the combination of antidepressant medication and immune checkpoint inhibitors
Participants will
Take olanzapine in combination with immune checkpoint inhibitors or immune checkpoint inhibitors alone for 2 months
Visit the clinic for check-ups and tests every two weeks and have follow-up visits every six weeks after the treatment ends
Keep a record of their symptoms and disease progression
The objective of this clinical trial is to determine whether antidepressant medications such as olanzapine in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone The main questions it aims to answer are
Is the combination therapy of antidepressant medication with immune checkpoint inhibitors more efficacious than the therapy with immune checkpoint inhibitors alone What medical issues might participants encounter when treated with the combination of antidepressant medication and immune checkpoint inhibitors
Participants will
Take olanzapine in combination with immune checkpoint inhibitors or immune checkpoint inhibitors alone for 2 months
Visit the clinic for check-ups and tests every two weeks and have follow-up visits every six weeks after the treatment ends
Keep a record of their symptoms and disease progression
Detailed Description:
An Open-label Two-arm Multicenter Phase II Randomized Controlled Study on the Impact of Olanzapine on the Efficacy of First-line Immunotherapy in Patients with Advanced EGFR Mutation-negative Non-small Cell Lung Cancer NSCLC
Primary Research Objective
To evaluate the objective response rate ORR in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine
Secondary Research Objectives
To evaluate the interval of progression-free survival iPFS in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine
To evaluate other antitumor efficacy indicators in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine progression-free survival PFS duration of response DoR and disease control rate DCR
To assess the safety Safety and the improvement of quality of life QoL in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine
To explore the impact of antipsychotic medication on the immune response to first-line immunotherapy in advanced NSCLC
Study Design
This study is an open-label two-arm multicenter phase II randomized controlled study designed to evaluate and observe the impact of olanzapine on the efficacy of first-line immunotherapy in patients with advanced EGFR mutation-negative NSCLC Eligible participants who meet all inclusion criteria and do not meet any exclusion criteria will receive first-line treatment with PD-1PD-L1 monoclonal antibodies alone or in combination with chemotherapy according to the instructions for use
Study Subjects
Ages 18 years and above including 18 and up to 75 years including 75 histologically or cytologically confirmed EGFR mutation-negative NSCLC intended to receive first-line treatment with PD-1PD-L1 inhibitors alone or in combination with chemotherapy
Inclusion Criteria
Participants voluntarily join this study and sign an informed consent form with good compliance and cooperation with follow-up
Age is 18 years and above including 18 and up to 75 years including 75 ECOG score 0-2 points Expected survival is no less than 3 months Staged as Stage IV according to the TNM system Confirmed to have NSCLC with EGFR mutation-negative by histology or cytology Has not received systemic antitumor treatment and is intended to receive first-line treatment with PD-1PD-L1 inhibitors alone or in combination with chemotherapy
Normal major organ function that is meeting the following criteria 1 Hematological examination criteria must be met Hb90 gL ANC15109L PLT80109L 2 Biochemical examination must meet the following criteria TBIL15ULN ALT and AST25ULN serum Cr125ULN or endogenous creatinine clearance 45 mlmin Cockcroft-Gault formula
Women of childbearing age must have taken reliable contraceptive measures and have undergone a pregnancy test serum or urine within 7 days before enrollment with a negative result and are willing to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication For men they must agree to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization
Data AnalysisStatistical Methods
Common Analysis This study will summarize the data using corresponding descriptive statistics according to the type of data that is for quantitative data mean Mean standard deviation SD median Median minimum value Minimum and maximum value Maximum will be used and for count data and grade data frequency and percentage will be used and time-event data will be estimated by the Kaplan-Meier method for the median time and the overall 95 confidence interval
Efficacy Analysis The primary efficacy endpoint the objective response rate ORR based on the investigators assessment will be compared between groups using the Fishers exact probability test and the two-sided 95 confidence interval will be listed
The secondary efficacy indicators including the interval of progression-free survival iPFS progression-free survival PFS duration of response DoR and disease control rate DCR will be estimated using the Kaplan-Meier method for the median time and the median event and the two-sided 95 confidence interval will be listed and the hazard ratio and its 95 confidence interval will be estimated The disease control rate DCR CR PR SD will be compared between groups using Fishers exact probability test and the two-sided 95 confidence interval will be listed Quality of life score statistical tests will use ANOVA or two-sided t-tests and a P-value less than or equal to 005 will be considered statistically significant Comparisons of changes before and after within groups will be made using paired t-tests
Safety Analysis Safety analysis will mainly summarize descriptive statistics Statistics will be summarized for adverse events AEs and treatment-emergent adverse events TEAEs serious adverse events SAEs and laboratory data vital signs etc At the same time statistical summaries will be made for the exposure to the study drug including treatment cycles total dose received and dose intensity The above data will be analyzed and summarized according to the current clinical trial reporting standards Including summary of adverse events all causes and related to treatment incidence and severity of adverse events all causes and related to treatment analysis of adverse events related to the drug analysis of the outcome of adverse events analysis of serious adverse events
Sample Size Estimation
This study is an open-label two-arm multicenter phase II randomized controlled study The primary research objective is to evaluate the objective response rate ORR in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine The study endpoint is the objective response rate ORR of the patients Referring to historical literature the ORR of first-line chemotherapy combined with immunotherapy in advanced NSCLC patients is about 50 and it is expected that the combination with olanzapine can increase the ORR by 15 After the first subject is enrolled the longest observation period is 24 months with α being two-sided 005 and the power being 90 the study plans to enroll 156 subjects with 78 in the experimental group and 78 in the control group calculated with a 10 loss to follow-up rate
Primary Research Objective
To evaluate the objective response rate ORR in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine
Secondary Research Objectives
To evaluate the interval of progression-free survival iPFS in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine
To evaluate other antitumor efficacy indicators in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine progression-free survival PFS duration of response DoR and disease control rate DCR
To assess the safety Safety and the improvement of quality of life QoL in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine
To explore the impact of antipsychotic medication on the immune response to first-line immunotherapy in advanced NSCLC
Study Design
This study is an open-label two-arm multicenter phase II randomized controlled study designed to evaluate and observe the impact of olanzapine on the efficacy of first-line immunotherapy in patients with advanced EGFR mutation-negative NSCLC Eligible participants who meet all inclusion criteria and do not meet any exclusion criteria will receive first-line treatment with PD-1PD-L1 monoclonal antibodies alone or in combination with chemotherapy according to the instructions for use
Study Subjects
Ages 18 years and above including 18 and up to 75 years including 75 histologically or cytologically confirmed EGFR mutation-negative NSCLC intended to receive first-line treatment with PD-1PD-L1 inhibitors alone or in combination with chemotherapy
Inclusion Criteria
Participants voluntarily join this study and sign an informed consent form with good compliance and cooperation with follow-up
Age is 18 years and above including 18 and up to 75 years including 75 ECOG score 0-2 points Expected survival is no less than 3 months Staged as Stage IV according to the TNM system Confirmed to have NSCLC with EGFR mutation-negative by histology or cytology Has not received systemic antitumor treatment and is intended to receive first-line treatment with PD-1PD-L1 inhibitors alone or in combination with chemotherapy
Normal major organ function that is meeting the following criteria 1 Hematological examination criteria must be met Hb90 gL ANC15109L PLT80109L 2 Biochemical examination must meet the following criteria TBIL15ULN ALT and AST25ULN serum Cr125ULN or endogenous creatinine clearance 45 mlmin Cockcroft-Gault formula
Women of childbearing age must have taken reliable contraceptive measures and have undergone a pregnancy test serum or urine within 7 days before enrollment with a negative result and are willing to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication For men they must agree to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization
Data AnalysisStatistical Methods
Common Analysis This study will summarize the data using corresponding descriptive statistics according to the type of data that is for quantitative data mean Mean standard deviation SD median Median minimum value Minimum and maximum value Maximum will be used and for count data and grade data frequency and percentage will be used and time-event data will be estimated by the Kaplan-Meier method for the median time and the overall 95 confidence interval
Efficacy Analysis The primary efficacy endpoint the objective response rate ORR based on the investigators assessment will be compared between groups using the Fishers exact probability test and the two-sided 95 confidence interval will be listed
The secondary efficacy indicators including the interval of progression-free survival iPFS progression-free survival PFS duration of response DoR and disease control rate DCR will be estimated using the Kaplan-Meier method for the median time and the median event and the two-sided 95 confidence interval will be listed and the hazard ratio and its 95 confidence interval will be estimated The disease control rate DCR CR PR SD will be compared between groups using Fishers exact probability test and the two-sided 95 confidence interval will be listed Quality of life score statistical tests will use ANOVA or two-sided t-tests and a P-value less than or equal to 005 will be considered statistically significant Comparisons of changes before and after within groups will be made using paired t-tests
Safety Analysis Safety analysis will mainly summarize descriptive statistics Statistics will be summarized for adverse events AEs and treatment-emergent adverse events TEAEs serious adverse events SAEs and laboratory data vital signs etc At the same time statistical summaries will be made for the exposure to the study drug including treatment cycles total dose received and dose intensity The above data will be analyzed and summarized according to the current clinical trial reporting standards Including summary of adverse events all causes and related to treatment incidence and severity of adverse events all causes and related to treatment analysis of adverse events related to the drug analysis of the outcome of adverse events analysis of serious adverse events
Sample Size Estimation
This study is an open-label two-arm multicenter phase II randomized controlled study The primary research objective is to evaluate the objective response rate ORR in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1PD-L1 inhibitors combined with olanzapine The study endpoint is the objective response rate ORR of the patients Referring to historical literature the ORR of first-line chemotherapy combined with immunotherapy in advanced NSCLC patients is about 50 and it is expected that the combination with olanzapine can increase the ORR by 15 After the first subject is enrolled the longest observation period is 24 months with α being two-sided 005 and the power being 90 the study plans to enroll 156 subjects with 78 in the experimental group and 78 in the control group calculated with a 10 loss to follow-up rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None