A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)
1 other identifier
observational
200
1 country
1
Brief Summary
Our project is going to clarify the efficacy and safety of Toripalimab in lung cancer in the real world, and to evaluate the incidence of adverse events (AEs) of special interest during Toripalimab immunotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 7, 2022
CompletedFirst Posted
Study publicly available on registry
December 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedDecember 15, 2022
December 1, 2022
4 years
December 7, 2022
December 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival(OS)
OS was calculated from the date of randomization to death from any cause.
2 years
Secondary Outcomes (4)
Progression Free Survival(PFS)
2 years
Overall Response Rate (ORR)
1 year
Disease Control Rate(DCR)
1 year
Health-related quality of life (HRQoL)
Within 1 year after starting Toripalimab treatment
Other Outcomes (1)
Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)
1 year
Study Arms (1)
Immunotherapy Regimen
Patients receiving different treatment regimens of Toripalimab in each center were consecutively enrolled from January 1, 2019 to December 31, 2022
Interventions
Toripalimab injection, recommended dose is 3 mg/kg, intravenous infusion every 2 weeks or 240 mg fixed dose, intravenous infusion every 3 weeks. Other treatment options are individualized according to the diagnosis and treatment experience of doctors in each center, diagnosis and treatment specifications and individual conditions of patients.
Eligibility Criteria
Consecutive lung patients treated with Toripalimab
You may qualify if:
- Age ≥ 18 years.
- Cytologically or histologically confirmed lung cancer.
- Complete clinical data.
- Indications for immunotherapy with Toripalimab.
You may not qualify if:
- Lack of patient key data.
- Refusal or uncooperation with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Qianfoshan Hospital
Study Record Dates
First Submitted
December 7, 2022
First Posted
December 15, 2022
Study Start
January 1, 2019
Primary Completion
December 31, 2022
Study Completion
June 1, 2023
Last Updated
December 15, 2022
Record last verified: 2022-12