A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)

Lung Cancer Clinical Trial

Official title:

A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652712
• Other study ID #: YXLL-KY-2022(80)
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2022
• Source: Qianfoshan Hospital
• Contact: Jiandong ZHANG
• Phone: (+86531)89269208
• Email: zhangjd165[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Tumor immunotherapy, as another important treatment after surgical treatment, chemoradiotherapy and targeted therapy, has achieved great success and gradually become one of the standard treatment methods for tumors. Toripalimab is the first Chinese PD-1 inhibitor approved for the treatment of nasopharyngeal carcinoma, malignant melanoma, urothelial carcinoma, esophageal squamous cell carcinoma and non-small cell lung cancer. It has been widely used in clinical practice. Several clinical studies have confirmed that it is safe and effective. In recent years, several clinical studies have reported that Toripalimab alone or in combination can improve the response rate of cancer treatment and improve survival. The results of Toripalimab research are mainly derived from rigorously designed randomized controlled trials (RCTs), and the efficacy and safety in the real world still need to be further explored. Real world studies, based on a large sample size, non-randomly select treatment measures according to the actual condition and wishes of patients, and pay attention to meaningful outcome treatment, which is closer to real clinical practice, without extrapolation difficulties, and has more clinical practical value. Therefore, it is of great significance to carry out a real-world study to investigate the differences in the efficacy and adverse reactions of Toripalimab immunotherapy in Chinese lung cancer patients in order to better guide clinical practice, which also provides research direction and data support for further prospective studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Cytologically or histologically confirmed lung cancer.

• Complete clinical data.

• Indications for immunotherapy with Toripalimab.

Exclusion Criteria:

• Lack of patient key data.

• Refusal or uncooperation with the study.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Toripalimab
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)	Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment. AEs/SAEs were evaluated using NCI-CTCAE v5.0	1 year
Primary	Overall survival(OS)	OS was calculated from the date of randomization to death from any cause.	2 years
Secondary	Progression Free Survival(PFS)	PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first.	2 years
Secondary	Overall Response Rate (ORR)	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters).	1 year
Secondary	Disease Control Rate(DCR)	The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.	1 year
Secondary	Health-related quality of life (HRQoL)	HRQoL measured by standardized EORTC questionaires (EORTC QLQ-C30)	Within 1 year after starting Toripalimab treatment