Back to resultsEffect of Daily Infusion Time of Immunotherapy on Overall Survival in NSCLC
Primary Purpose
Non-small Cell Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Time of immunotherapy infusion
Sponsored by
About this trial
This is an interventional prevention trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with untreated non-small cell lung cancer
- ECOG score 0-2
- Asymptomatic brain metastases
- Driver gene was negative
- At least 1 measurable lesion
- First-line patients received immunological monotherapy or immunological combined chemotherapy
Exclusion Criteria:
- Failure to follow the standard treatment plan during diagnosis and treatment;
- Lack of clinical diagnosis and treatment information or loss of follow-up;
- Can't tolerate immunotherapy or ECOG score greater than 2
Sites / Locations
- Hunan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
morning group
afternoon group
Arm Description
The immunotherapy infusion is after 9:00 a.m
The immunotherapy infusion is after 15:00 p.m
Outcomes
Primary Outcome Measures
ORR
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
OS
Defined as the time from the start of treatment to the death of the subject due to any cause.
Secondary Outcome Measures
Full Information
NCT ID
NCT05549037
First Posted
September 17, 2022
Last Updated
December 7, 2022
Sponsor
Hunan Province Tumor Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05549037
Brief Title
Effect of Daily Infusion Time of Immunotherapy on Overall Survival in NSCLC
Official Title
Effect of Daily Infusion Time of Immunotherapy on Overall Survival in Patients With Advanced Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
December 2, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunan Province Tumor Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to explore the effect of different infusion times (day or night) on the efficacy of immune checkpoint inhibitors on the basis of real-world efficacy of immunotherapy for advanced squamous/non-squamous non-small cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
morning group
Arm Type
Experimental
Arm Description
The immunotherapy infusion is after 9:00 a.m
Arm Title
afternoon group
Arm Type
Experimental
Arm Description
The immunotherapy infusion is after 15:00 p.m
Intervention Type
Procedure
Intervention Name(s)
Time of immunotherapy infusion
Intervention Description
Time of immunotherapy infusion
Primary Outcome Measure Information:
Title
ORR
Description
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Time Frame
1 year
Title
OS
Description
Defined as the time from the start of treatment to the death of the subject due to any cause.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with untreated non-small cell lung cancer
ECOG score 0-2
Asymptomatic brain metastases
Driver gene was negative
At least 1 measurable lesion
First-line patients received immunological monotherapy or immunological combined chemotherapy
Exclusion Criteria:
Failure to follow the standard treatment plan during diagnosis and treatment;
Lack of clinical diagnosis and treatment information or loss of follow-up;
Can't tolerate immunotherapy or ECOG score greater than 2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongchang C Zhang, MD
Phone
+8613873123436
Ext
7+861383123436
Email
zhangyongchang@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Nong Yang, MD
Phone
+8613873123436
Ext
+8613873123436
Email
yangnong0217@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongchang Zhang, MD
Organizational Affiliation
Hunan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongchang Zhang, MD
Phone
+86 731 89762323
Email
zhangyongchang@csu.edu.cn
First Name & Middle Initial & Last Name & Degree
Nong Yang, MD
Phone
+86 731 89762321
Email
yangnong0217@163.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Daily Infusion Time of Immunotherapy on Overall Survival in NSCLC
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