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Completed

NCT Number: NCT05805267

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

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

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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

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

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

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: 2 year

    Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

Secondary outcomes

  1. ORR

    Time frame: 2 years

    Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Apr 7, 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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