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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with non-small cell lung cancer who have previously received single-agent K therapy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression free survival time	October 2022-December 2022
ORR	Objective response rate	October 2022-December 2022
Consistency	he consistency of efficacy between specified kit and 22C3	October 2022-December 2022

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital
• Investigators: Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ART

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No