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Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in NSCLC

Sponsor
Peking Union Medical College (Other)
Overall Status
Recruiting
CT.gov ID
NCT05458726
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
25.5
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Research on the Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via Digital Droplet PCR (ddPCR) From Peripheral Blood in NSCLC Patients
Actual Study Start Date :
Sep 15, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Osimertinib

Osimertinib 80mg po daily

Drug: Osimertinib
Osimertinib or chemotherapy
Other Names:
  • paclitaxel
  • carboplatin
  • pemetrexed

    		•
    Sham Comparator: Other treatments

    chemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents

    Drug: Osimertinib
    Osimertinib or chemotherapy
    Other Names:
  • paclitaxel
  • carboplatin
  • pemetrexed

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PFS [up to 1 year]

      Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause

    Secondary Outcome Measures

    1. ORR [up to 1 year]

      the sum of CR and PR rates

    2. DCR [up to 1 year]

      the sum of CR ,PR and SD rates

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations;

    • progression from first or second-generation EGFR-TKI confirmed by radiographic imaging;

    • received both NGS test and ddPCR from peripheral blood simultaneously.

    Exclusion Criteria:

    • progression from first- or second-generation EGFR-TKIs as adjuvant therapy;

    • having received third-generation EGFR-TKIs prior to the gene tests;

    • having received NGS test only or ddPCR test only.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Junling Li Beijing Beijing China 100021

    Sponsors and Collaborators

    • Peking Union Medical College

    Investigators

    • Principal Investigator: Junling Li, Professor, Chinese Academy of Medical Sciences and Peking Union Medical College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Junling Li, Professor, Peking Union Medical College
    ClinicalTrials.gov Identifier:
    NCT05458726
    Other Study ID Numbers:
    • NCC-005374
    First Posted:
    Jul 14, 2022
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Paclitaxel
    Carboplatin
    Pemetrexed
    Osimertinib

    Study Results

    No Results Posted as of Jul 26, 2022