Clincosm LogoSign in Get a demo

Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced NSCLC

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04324164
Collaborator
(none)
800
Enrollment
1
Location
45
Anticipated Duration (Months)
17.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    inclusion criteria Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer EGFR G719X, exon 20 insert mutation without any anti-cancer treatment history

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China
    Actual Study Start Date :
    Mar 24, 2020
    Anticipated Primary Completion Date :
    Dec 24, 2022
    Anticipated Study Completion Date :
    Dec 24, 2023

    Outcome Measures

    Primary Outcome Measures

    1. PFS [may 2020- may 2021 (1 year)]

      Progression free survival

    Secondary Outcome Measures

    1. OS [may 2020- may 2021 (1 year)]

      Overall survival

    2. ORR [may 2020- may 2021 (1 year)]

      To measure the patients's overall response rate

    Eligibility Criteria

    Criteria

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

    • 18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology

    • Uncommon EGFR Mutant Advanced NSCLC

    Exclusion Criteria:

    • Patients with contraindication of chemotherapy

    • Pregnant or breast feeding women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yongchang Zhang Changsha Hunan China 410013

    Sponsors and Collaborators

    • Hunan Province Tumor Hospital

    Investigators

    • Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongchang Zhang, professor, Hunan Province Tumor Hospital
    ClinicalTrials.gov Identifier:
    NCT04324164
    Other Study ID Numbers:
    • SONICS
    First Posted:
    Mar 27, 2020
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Mar 2, 2022