Multicenter Observational Study of Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Rare Driver Gene Mutation

NCT04137718 | Unknown DMC

• 1 other identifier: LC-IRICA
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chinese; Non-Small Cell Lung Cancer

Keywords

Multicenter; Observational Study; NSCLC; Rare Driver Gene

Outcome Measures

Primary Outcomes (3)

• Driver gene mutation frequency of Chinese NSCLC patients

  Analyze the rare driver gene mutation frequency in NSCLC patients in the real world.

  2022

• 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

• 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 Outcomes (3)

• Objective response rate of Chinese NSCLC patients With Rare Driver Gene Mutation

  2024

• Progression-free survival of Chinese NSCLC patients With Rare Driver Gene Mutation

  2024

• Overall survival of Chinese NSCLC patients With Rare Driver Gene Mutation

  2024

Study Arms (2)

Rare driver gene mutation-positive

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation positive.

Other: nonIntervention

Rare driver gene mutation-negative

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction(PCR)panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation negative.

Other: nonIntervention

Interventions

nonIntervention OTHER

nonIntervention

Rare driver gene mutation-negative; Rare driver gene mutation-positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically or cytologically proven diagnosis of NSCLC

You may qualify if:

• Female or male, 18 years of age or older；
• Histologically or cytologically proven diagnosis of NSCLC；
• Able to get tumor tissue gene testing results by lung cancer PCR panel kit carried out in hospital；
• Signed and dated informed consent。

You may not qualify if:

• Combine with other tumor type
• The investigator judges the situation that may affect the clinical search process and results

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (7)

• 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 Nov;24(11):e1070-e1081. doi: 10.1634/theoncologist.2018-0572. Epub 2019 Mar 22.

  PMID: 30902917 RESULT

• 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. Structural, biochemical, and clinical characterization of epidermal growth factor receptor (EGFR) exon 20 insertion mutations in lung cancer. Sci Transl Med. 2013 Dec 18;5(216):216ra177. doi: 10.1126/scitranslmed.3007205.

  PMID: 24353160 RESULT

• 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.

  PMID: 29488330 RESULT

• 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.

  PMID: 28818606 RESULT

• 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 Systematic Review and Meta-analysis. JAMA Oncol. 2018 Feb 1;4(2):210-216. doi: 10.1001/jamaoncol.2017.4427.

  PMID: 29270615 RESULT

• 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.

  PMID: 30225210 RESULT

• 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.

  PMID: 29182164 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Caicun Zhou

CONTACT

86-21-65115006; caicunzhou@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 24, 2019
• Study Start: October 25, 2019
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2024
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)