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Completed

NCT Number: NCT05450081

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunan Cancer hospital

Changsha, Hunan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: October 2022-December 2022

    Progression free survival time

  2. ORR

    Time frame: October 2022-December 2022

    Objective response rate

  3. Consistency

    Time frame: October 2022-December 2022

    he consistency of efficacy between specified kit and 22C3

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2022
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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