Clinical trial NCT05652712: A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)
Official title: A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive lung patients treated with Toripalimab

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival(OS)
timeFrame: 2 years
Secondary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 2 years
measure: Overall Response Rate (ORR)
timeFrame: 1 year
measure: Disease Control Rate(DCR)
timeFrame: 1 year
measure: Health-related quality of life (HRQoL)
timeFrame: Within 1 year after starting Toripalimab treatment
Other outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)
timeFrame: 1 year
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: