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PIKACHU: PD-1 Antibody Plus Chemotherapy for TKI Failure Driver Gene Mutation Positive Advanced NSCLC

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04322890
Collaborator
(none)
100
Enrollment
1
Location
45
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of PD-1 antibody plus Chemotherapy for TKI Failure EGFR/ALK/ROS1 mutation-positive advanced Non-small cell lung cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Enrolled criteria EGFR mutation-positive advanced NSCLC ALK or ROS1 fusion-positive advanced NSCLC Failed with standard TKI therapy

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    PD-1 Antibody Plus Chemotherapy for TKI Failure EGFR/ALK/ROS1 Mutation Positive Advanced Non-small Cell Lung Cancer
    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
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • advanced non-small cell lung cancer

    • EGFR/ALK/ROS1 mutation positive

    • performance status（0-1)

    Exclusion Criteria:

    • other genes mutation

    • saquamous

    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:
    NCT04322890
    Other Study ID Numbers:
    • PIKACHU
    First Posted:
    Mar 26, 2020
    Last Update Posted:
    Mar 10, 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 10, 2022