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A Non-interventional Study With Extensive Stage Small Cell Lung Cancer

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05991180
Collaborator
(none)
160
Enrollment
1
Location
28
Anticipated Duration (Months)
5.7
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 :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Non-interventional Study and Its Clinical Relevance With Extensive Stage Small Cell Lung Cancer
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. ORR [2 years]

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

    Secondary Outcome Measures

    1. PFS [2 years]

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

    2. OS [2 years]

      Defined as the time from the start of treatment to the death of the subject due to any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients must be ≥18 years.

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

    • Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).

    • 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:
    NCT05991180
    Other Study ID Numbers:
    • BELIEVE RWS
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of Aug 14, 2023