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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04137718
Other study ID # LC-IRICA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 25, 2019
Est. completion date October 20, 2024

Study information

Verified date December 2019
Source Shanghai Pulmonary Hospital, Shanghai, China
Contact Caicun Zhou
Phone 86-21-65115006
Email caicunzhou@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Title: Multicenter observational study for clinicopathological characteristics and clinical efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) patients With Rare Driver Gene Mutation.

Purpose: To observe the status of rare driver gene mutations in NSCLC patients and identify the subtypes of the mutations.

By comparing and analyzing the relationship between different subtypes, clinicopathological features and clinical efficacy, to find out the effects on anti-tumor therapy and disease survival.

And ultimately to promote the precise application of clinical specifications for new anti-tumor drugs.

Study type: Observational


Description:

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Study Design


Intervention

Other:
nonIntervention
nonIntervention

Locations

Country Name City State
China Shanghai Pulmonary Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary Driver gene mutation frequency of Chinese NSCLC patients Analyze the rare driver gene mutation frequency in NSCLC patients in the real world. 2022
Primary Clinicopathological characteristics of Chinese NSCLC patients With Rare Driver Gene Mutation Observe the clinicopathological features in NSCLC patients with rare gene mutation in the real world. 2022
Primary Relationship of Clinicopathological characteristics and Rare Driver Gene Mutation of Chinese NSCLC patients Analyze the relationship between rare driver gene subtypes and clinicopathological features in NSCLC patients. 2022
Secondary Objective response rate of Chinese NSCLC patients With Rare Driver Gene Mutation The relationship between rare driver gene mutation subtypes and objective response rate in NSCLC patients.
Objective response rate(ORR): ORR = (number of subjects with complete response (CR) + partial response (PR)) / total number of subjects × 100%, 95% confidence interval(CI) was calculated using binomial distribution, and the calculation of objective response rate was based on the quadratic confirmed optimal efficacy evaluation.
2024
Secondary Progression-free survival of Chinese NSCLC patients With Rare Driver Gene Mutation The relationship between rare driver gene mutation subtypes and progression-free survival in NSCLC patients.
Progression-free survival (PFS): PFS refers to the time (month) between the date of randomization to the first demonstration of disease progression or death (whichever occurs first).
2024
Secondary Overall survival of Chinese NSCLC patients With Rare Driver Gene Mutation The relationship between rare driver gene mutation subtypes and overall survival in NSCLC patients.
Overall survival (OS): OS refers to the time of first use of the drug to the time of death. At the end of the study, if the subject is still alive, refer the known "date of last survival of the subject" as the date of censoring.
2024
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