Non-Small Cell Lung Cancer Clinical Trial
Official title:
Multicenter Observational Study for Clinicopathological Characteristics and Clinical Efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation
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 |
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
Status | Recruiting |
Enrollment | 50000 |
Est. completion date | October 20, 2024 |
Est. primary completion date | October 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Female or male, 18 years of age or older; 2. Histologically or cytologically proven diagnosis of NSCLC; 3. Able to get tumor tissue gene testing results by lung cancer PCR panel kit carried out in hospital; 4. Signed and dated informed consent? Exclusion Criteria: 1. Combine with other tumor type 2. The investigator judges the situation that may affect the clinical search process and results |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Pulmonary Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Pulmonary Hospital, Shanghai, China |
China,
Drilon A, Hu ZI, Lai GGY, Tan DSW. Targeting RET-driven cancers: lessons from evolving preclinical and clinical landscapes. Nat Rev Clin Oncol. 2018 Mar;15(3):150. doi: 10.1038/nrclinonc.2017.188. Epub 2017 Nov 28. — View Citation
Du X, Shao Y, Qin HF, Tai YH, Gao HJ. ALK-rearrangement in non-small-cell lung cancer (NSCLC). Thorac Cancer. 2018 Apr;9(4):423-430. doi: 10.1111/1759-7714.12613. Epub 2018 Feb 28. Review. — View Citation
Lee CK, Man J, Lord S, Cooper W, Links M, Gebski V, Herbst RS, Gralla RJ, Mok T, Yang JC. Clinical and Molecular Characteristics Associated With Survival Among Patients Treated With Checkpoint Inhibitors for Advanced Non-Small Cell Lung Carcinoma: A Syste — View Citation
Lin JJ, Shaw AT. Recent Advances in Targeting ROS1 in Lung Cancer. J Thorac Oncol. 2017 Nov;12(11):1611-1625. doi: 10.1016/j.jtho.2017.08.002. Epub 2017 Aug 14. Review. — View Citation
Wen S, Dai L, Wang L, Wang W, Wu D, Wang K, He Z, Wang A, Chen H, Zhang P, Dong X, Dong YA, Wang K, Yao M, Wang M. Genomic Signature of Driver Genes Identified by Target Next-Generation Sequencing in Chinese Non-Small Cell Lung Cancer. Oncologist. 2019 No — View Citation
Yasuda H, Park E, Yun CH, Sng NJ, Lucena-Araujo AR, Yeo WL, Huberman MS, Cohen DW, Nakayama S, Ishioka K, Yamaguchi N, Hanna M, Oxnard GR, Lathan CS, Moran T, Sequist LV, Chaft JE, Riely GJ, Arcila ME, Soo RA, Meyerson M, Eck MJ, Kobayashi SS, Costa DB. S — View Citation
Zhou F, Zhou C. Lung cancer in never smokers-the East Asian experience. Transl Lung Cancer Res. 2018 Aug;7(4):450-463. doi: 10.21037/tlcr.2018.05.14. Review. — View Citation
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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