Effect of Daily Infusion Time of Immunotherapy on Overall Survival in NSCLC

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05549037
Collaborator
(none)
112
1
2
23.9
4.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Time of immunotherapy infusion
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Daily Infusion Time of Immunotherapy on Overall Survival in Patients With Advanced Non-small Cell Lung Cancer
Actual Study Start Date :
Jan 2, 2022
Anticipated Primary Completion Date :
Dec 2, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: morning group

The immunotherapy infusion is after 6:00 p.m

Procedure: Time of immunotherapy infusion
Time of immunotherapy infusion

Experimental: afternoon group

The immunotherapy infusion is after 6:00 p.m

Procedure: Time of immunotherapy infusion
Time of immunotherapy infusion

Outcome Measures

Primary Outcome Measures

  1. ORR [1 year]

    Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

  2. OS [1 year]

    Defined as the time from the start of treatment to the death of the subject due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hunan Cancer Hospital Changsha Hunan China 410013

Sponsors and Collaborators

  • Hunan Province Tumor Hospital

Investigators

  • Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yongchang Zhang, Director, Head of Medical Oncology, Principal Investigator, Clinical Professor, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier:
NCT05549037
Other Study ID Numbers:
  • INJECTION
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 27, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2022