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A Non-interventional Study With Central Nervous System Metastatic EGFR Mutation Positive NSCLC

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05991193
Collaborator
(none)
100
Enrollment
1
Location
28.6
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Non-interventional Study and Its Clinical Relevance With Central Nervous System Metastatic Epidermal Growth Factor Receptor Mutation Positive Non-small Cell Lung Cancer
    Anticipated Study Start Date :
    Aug 15, 2023
    Anticipated Primary Completion Date :
    Aug 30, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [2 years]

      Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.

    Secondary Outcome Measures

    1. Central nervous system (CNS) progression-free survival [2 years]

      CNS PFS is defined as the time from beginning of study treatment until the date of objective progression of central nervous system or death (by any cause in the absence of CNS progression), regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy prior to progression.

    2. Objective Response Rate [2 years]

      Defined as the number (%) of patients with response of Complete Response or Partial Response

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must be ≥18 years.

    • Provision of fully informed consent prior to any study specific procedures.

    • Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically. The mutations above may exist alone or together.

    • Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC).

    • According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hunan Cancer hospital Changsha Hunan China

    Sponsors and Collaborators

    • Hunan Province Tumor Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongchang Zhang, Professor, Deputy Director of Thoracic Oncology Department, Hunan Province Tumor Hospital
    ClinicalTrials.gov Identifier:
    NCT05991193
    Other Study ID Numbers:
    • FORCE RWS
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 14, 2023