Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients

Non-small Cell Lung Cancer Clinical Trial

Official title:

Clinical Trials to Evaluate the Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients With Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05450081
• Other study ID #: ART
• Status: Completed
• Start date: June 30, 2022
• Est. completion date: October 1, 2023

Study information

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

Clinical Trial Summary

Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1)=18,advanced non-small cell lung cancer confirmed by histopathology, and were previously or currently treated with gefitinib tablets (as the first-line treatment) or osimertinib (first-generation TKI resistance treatment) or crizotinib capsules monotherapy were evaluated for efficacy.

• 2) Able to provide FFPE samples with a storage life of 5 years: Large specimen 5 pieces in each case; 10 puncture specimens in each case

Exclusion Criteria:

• 1) Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells >20%);

• 2) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;

• 3) Maintenance treatment when the disease does not progress after other anti-tumor treatments.

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	Progression free survival time	October 2022-December 2022
Primary	ORR	Objective response rate	October 2022-December 2022
Primary	Consistency	he consistency of efficacy between specified kit and 22C3	October 2022-December 2022