To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805267
• Other study ID #: CONFIDENCE II
• Status: Completed
• Start date: September 20, 2022
• Est. completion date: March 25, 2023

Study information

• Verified date: March 2023
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluated the correlation between the qualitative test results of Xiamen Aide the gene test specified by the test reagent and the efficacy of relevant targeted drugs in patients with non-small cell lung cancery, and the research data is used to support the registration and marketing of the assessment reagent

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 25, 2023
• Est. primary completion date: February 25, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1)=18;
• 2) advanced non-small cell lung cancer confirmed by histopathology;
• 3) Patients with NSCLC who have previously or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy, and the response to treatment can be assessed;
• 4) Have sufficient FFPE tissue samples within 5 years: 5 large specimens/case; There were 10 puncture specimens/case

Exclusion Criteria:

• 1) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
• 2)Maintenance therapy if the disease does not progress after treatment with other antitumor methods

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
China	Hunan Cancer hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	2 year
Secondary	ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	2 years